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Dissertations / Theses on the topic 'Pharmaceutical technology'

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Published: 4 June 2021
Last updated: 30 July 2024

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1

Barrett, Angela Mary Chemical Sciences &amp Engineering Faculty of Engineering UNSW. "Pharmaceutical processing using dense gas technology." Publisher:University of New South Wales. Chemical Sciences & Engineering, 2008. http://handle.unsw.edu.au/1959.4/41333.

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There exists a demand to re-engineer pre-existing pharmaceuticals to provide improved drug delivery, new dosage forms and increased drug safety and efficacy. Furthermore, the development of novel methods and formulations allows for the patent life of pre-existing drugs to be extended, which has obvious economic benefits for pharmaceutical companies. Dense gas technology provides a means to achieve these aims and to overcome the distinct limitations of traditional technologies. A novel formulation of the antifungal drug itraconazole has been developed using gas antisolvent processes. The new itraconazole-polymer formulation displayed a significant improvement in dissolution rate achieving 89.8 % dissolution compared to 52.5 % for the commercial formulation. The results of this study demonstrate the great opportunity to use dense gases for the creation of novel drug-polymer composite formulations with improved dissolution properties. The impregnation of an active ingredient into a polymer matrix is another method that can be used to improve the dissolution of poorly water soluble drugs. Dense gas technology has been incorporated into traditional methods for the formation of porous polymer matrices decreasing process residence times. However, some issues still need to be overcome including high operating temperatures and the use of class 3 solvents. A novel dense gas process for the formation of a porous polymer hydrogel matrix has been developed to improve upon current methodologies; Dense Gas Solvent Exchange Process (DGSEP). The Dense Gas Solvent Exchange Process was used to create a porous chitosan hydrogel impregnated with a stable amorphous form of the drug griseofulvin. Furthermore, the process was extended to include a hydrophilic polymer into the matrix. The resulting formulation had a dramatically improved dissolution rate achieving complete dissolution within 70 minutes compared with the commercial formulation which achieved less than 40 %dissolution in the same time. There is great potential for DGSEP to be applied to the formation of a variety of polymer hydrogels impregnated with active ingredients and incorporating polymers and other compounds. The significance of these results is that a simple and effective processing method has been developed to produce hydrogel systems that are suitable for the development of a diverse range of drug delivery systems.
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2

Peterson, Olga Yuris. "Transferring pharmaceutical batch technology to continuous flow." Thesis, Georgia Institute of Technology, 2011. http://hdl.handle.net/1853/39510.

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The current trend in the pharmaceutical industry is towards continuous flow processes. Continuous flow reactor technology can produce a cheaper, better quality product at reduced energy and environmental cost through more efficient mass and heat transfer. It also enables a simplified and faster approach to bulk production by scaling out as opposed to scaling up. The research presented here focuses on the configuration and installation of a continuous flow system into the laboratory, and the transfer of a Meerwein-Ponndorf-Verley (MPV) reduction from batch to continuous mode. The Corning® glass continuous flow reactor in our laboratory utilizes specially-designed mixing structures for enhanced mass transfer. Additionally, the glass reactor offers nonreactivity and corrosion resistance over a wide range of temperature and pressure, which conventional steel reactors do not allow. The MPV reduction is a well-known method to prepare primary and secondary alcohols from aldehydes and ketones, respectively. The traditional MPV reduction protocol (Al(OiPr)₃ in isopropanol) was modified to enable the technological transfer from batch to continuous mode. This is the first time MPV reduction reactions were carried out in continuous mode. As a result, the MPV reduction of the model compound, benzaldehyde, was successfully conducted with 60% less catalyst and product yield was improved up to 20% (average of 10%) in continuous flow reactions as compared to current batch technology. These results are being used to develop a technology roadmap for the pharmaceutical industry to implement continuous flow processes in their manufacturing operations.
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3

Grobler, Anne Frederica. "Pharmaceutical applications of PheroidTM technology / Anne F. Grobler." Thesis, North-West University, 2009. http://hdl.handle.net/10394/6701.

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For a drug to have a therapeutic effect, it has to reach its site of action in sufficient quantities. The Pheroid drug delivery system enhances the absorption of drugs in various pharmacological categories and is the focus of this study. A number of patents are registered in various countries to protect its application. Pheroid technology is trademarked, but may for ease of reading, be called Pheroid(s) only. The Pheroid itself is composed of an organic carbon backbone composed of unsaturated fatty acids with some side-chain interactions that result in self-emulsifying characteristics. The resulting vesicles and nano-sponges can entrap hydrophilic, hydrophobic or amphiphilic compounds for biomedical and agricultural application and can be manipulated as to loading ability, mechanical resistance, permeability, size and solubility. Pheroid was investigated for its potential use in the areas of vaccines, peptide drugs, topical products and cosmeceuticals, antimicrobial treatments and agriculture. In all of these areas, the Pheroid has indeed shown applicability: the results showed improved uptake and/or efficacy of the entrapped chemical or biological compounds after administration by a number of administration routes. For oral administration, a precursor format, the pro-Pheroid, was used, wherein the vesicles and/or sponges are formed post-administration. Proof of concept studies on the in vivo absorption and bioavailability, as well as studies on in vitro efficacy of Pheroid-based formulations were carried out for antimicrobials, such as tuberculosis drugs, antimalarials and antiretrovirals. In all cases, the in vitro efficacy of the active compounds was increased, compared to well-known standard drug treatments. In a phase I bio-equivalence study, a Pheroid-containing combination formulation was compared against the comparative market leader. The results demonstrated that the bioavailability of the active compounds in the Pheroid was at least as good but mostly significantly better than that of the comparative medication. In addition, the incidence of side-effects was decreased in the case of the Pheroid formulations. Furthermore, in vitro results indicate that drug resistance can at least partially be negated. Pheroid technology may also be capable of protecting labile drugs such as peptides against degradation and increasing efficacy so that lower dosages can be administered less frequently and with fewer side effects. Based on in vitro and in vivo results, a number of products are currently in development. The application of Pheroid technology is potentially limitless and includes such areas as TB, malaria, cancer, AIDS, gene delivery, vaccines, patented medicines and generics and agriculture.
Thesis (Ph.D. (Pharmaceutics))--North-West University, Potchefstroom Campus, 2010.
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4

HAUSMAN-MANNING, DEBRA SUE. "APPLICATION OF PROCESS ANALYTICAL TECHNOLOGY TO PHARMACEUTICAL PROCESSES." University of Cincinnati / OhioLINK, 2005. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1108838053.

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5

Jadav, Niten B. "Novel Technology for Crystal Engineering of Pharmaceutical Solids." Thesis, University of Bradford, 2018. http://hdl.handle.net/10454/18177.

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The research work described in this thesis, the environmentally friendly novel "Microwave Assisted Sub-Critical water (MASCW)" technology for particle engineering of active pharmaceutical ingredients and excipients was developed. The present novel technology MASCW process is described as green technology as water is used as the solvent medium and microwave energy as external source of heat energy for generation of a particle with different morphological and chemical properties. In MASCW process supersaturated solution of APIs is prepared by dissolving solute in water at high temperature and pressure conditions. Upon rapid and controlled cooling, based on the aqueous solubility of solute, solute/solvent concentration and dielectric constant of water rapid precipitation of API with narrow particle size distribution occurs. Using paracetamol (pca) as API moiety understanding of the mechanism of MASCW crystallisation process was investigated. The effect of different process and experimental parameters on crystallisation pathway and end product attributes were analysed. Correlation between the degree of supersaturation concentration of pca solution against temperature and pressure parameters was explained by generating binary phase diagram. Determination of polymorphic transformation pathway of pca from form I (stable) to form II metastable polymorphs in solution was analysed using Raman spectroscopy. The difference between conventional heating and subcritical treatment was explored by determining the change in the solvent dielectric constant and solubility of hydrophobic API molecule. Based on the process understanding results, this technology was further implemented to explore its application in generating phase pure stable and metastable cocrystal phase. Based on the solubility of API and cocrystal former congruent (CBZ/SAC, SMT/SAC, SMZ/SAC) and incongruent (CAF/4HBA) cocrystal pairs were selected. For the first time generation of anhydrous phase of CAF: 4HBA cocrystal in 1:1 stoichiometric ration was reported and generation of metastable cocrystal phase of CA CBZ: SAC form II was reported. The application of this technology was explored in generating phase pure metastable polymorph of paracetamol which retain higher compressibility and dissolution rate. The potential of MASCW micronisation process, theophylline is used as the model component to produce micro sized particles for pulmonary drug delivery system via dry powder inhaler (Foradil inhaler). The results demonstrate that the THF particles generated using MASCW process displayed greater aerodynamic performance compared to conventional spray-dried THF sample. In the final chapter, synthesis of inorganic biomaterial (nano crystalline hydroxyapatite) was reported for the first time and the prospects of combining API like ibuprofen (IBU) with a biologically active component like nano-crystalline hydroxyapatite (HA) through hydrogen bonding was mechanistically explained using X-ray diffractometer and spectroscopic techniques.
The full text will be available at the end of the embargo: 16th May 2021
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6

Calogerà, Giacomo <1976&gt. "An Investigation Into the Pharmaceutical Melt Granulation Technology." Doctoral thesis, Alma Mater Studiorum - Università di Bologna, 2010. http://amsdottorato.unibo.it/2939/1/Caloger%C3%A0_Giacomo_tesi.pdf.

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7

Calogerà, Giacomo <1976&gt. "An Investigation Into the Pharmaceutical Melt Granulation Technology." Doctoral thesis, Alma Mater Studiorum - Università di Bologna, 2010. http://amsdottorato.unibo.it/2939/.

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8

Yu, Shen. "Roll compaction of pharmaceutical excipients." Thesis, University of Birmingham, 2013. http://etheses.bham.ac.uk//id/eprint/4137/.

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Roll compaction is commonly used as a dry granulation technique in the pharmaceutical industry to produce tablets for formulations sensitive to heat and moisture. This thesis reports systematic studies on the behavior of pharmaceutical excipients in associated unit operations (i.e. roll compaction, milling, tabletting), as well as their correlations. Roll compaction experiments were carried out using an instrumented roll compactor with a gravity feeding system. The influence of the process parameters, material properties and powder conditioning were investigated Ribbons produced in roll compaction were granulated using an oscillating mill to investigate the milling process. A first order kinetics equation was introduced to describe the mass throughput of the granules. Using positron emission particle tracking technique, which provided a measurement of instantaneous velocity and the location of the ribbons, two milling regions (i.e. impact and abrasion) involving distinct fracture mechanisms were identified. Tabletting of the granules was performed using a universal test machine. A reduction in the compressibility and compactibility of the granules compared to the feed powders, due to work hardening, was also observed. A method was introduced to determine the optimized process conditions for roll compaction and milling through a close examination of the correlation between the unit operations.
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9

Velaga, Sitaram P. "Preparation of Pharmaceutical Powders using Supercritical Fluid Technology : Pharmaceutical Applications and Physicochemical Characterisation of Powders." Doctoral thesis, Uppsala : Acta Universitatis Upsaliensis : Univ.-bibl. [distributör], 2004. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-4006.

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10

Mascia, Salvatore. "Rheology and processing of pharmaceutical pastes." Thesis, University of Cambridge, 2008. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.612373.

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11

Ramirez, Paulina. "Globalisation, technology and organisational change in the pharmaceutical industry." Thesis, University of Manchester, 2003. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.488301.

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12

Waring, Michael John. "Acoustic emission of pharmaceutical materials during compaction." Thesis, Liverpool John Moores University, 1990. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.291285.

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13

Lee, Jae You. "Technology strategies and the choice of mode in foreign technology acquisition : a case study of the Korean pharmaceutical firms /." Thesis, Connect to this title online; UW restricted, 1988. http://hdl.handle.net/1773/8805.

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14

Smith, Kenneth Baird. "Crystallisation of active pharmaceutical ingredients using ionic liquids." Thesis, University of Birmingham, 2015. http://etheses.bham.ac.uk//id/eprint/6039/.

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It is proposed that Ionic Liquids offer a new opportunity for exploration into a novel medium for processing Active Pharmaceutical Ingredients, particularly with respect to habit control and polymorphic form. A review of relevant literature relating to ionic liquids properties, commercial applications and current research has been summarised together with background into fundamental crystallisation theory. Crystallisations using thermal methods were employed at laboratory scale and the physical properties of the resultant powders were analysed and compared to commonly encountered crystal forms. For paracetamol it was found that the morphology of the crystals could be manipulated, producing in some cases, habits not reported for conventional organic solvent crystallisation. This was achieved through changing both the IL used and the saturation of the system whilst in all cases retaining the most stable polymorph. ILs ILs to be ‘designed’ for a given API but greater understanding of the interactions between IL and solute are required first. Properties such as increased solvation power, thermal stability, liquidus range and low vapour pressure bring a number of advantages when designing industrial crystallisations. However ILs also have a number of disadvantages including phase separation problems.
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15

Ju, Dehao. "Experimental and numerical research on pharmaceutical aerosols." Thesis, University of Southampton, 2012. https://eprints.soton.ac.uk/348916/.

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With the background of health issues regarding the consumption of tobacco, the widespread availability of safer nicotine products and a harm reduction policy is encouraged. A cigarette alternative is designed to deliver a dose of medicinal nicotine within a timeframe comparable to that of a cigarette, and gives much of what smokers expect from a cigarette without the risks of smoking tobacco. The general purpose of this Ph.D. project is to study the process of flashing atomization and dispersion, with a view to supporting the development of a cigarette replacement device. In order to test the effectiveness of the nicotine formulations, the analysis is carried out sizing the droplets of the aerosols at the position where human oropharynx locates, to support the further research on the deposition of droplets in the human respiratory tract. A mechanical lung has been assembled and programmed to trigger the ‘cigarette-like’ devices with different inhalation profiles, and a dual laser system has been designed to measure the global actuation flow characteristics (e.g. spray velocity and opacity). In order to efficiently acquire sufficient droplet information (e.g. diameter and aspect ratio) from images of in and out of focus droplets, a multi-threshold algorithm is developed and successfully implemented in the automatic particle/droplet image analysis (PDIA) system. It increases the depth of field (DoF) of small particles with diameters smaller than 50μm, and it performs more efficiently than the dual threshold methods which are widely used in the commercial software. A numerical multi-component two-phase actuation flow model has been developed, in order to test different formulations within various flow domains of the cigarette replacement devices. The simulated results of the numerical model have been validated with the experimental measurements and the results of previous researchers. In order to acquire an aerosol with relatively low and steady mass flow rate of nicotine, it is recommended that the mass fraction of propellant (HFA 134a) should be kept around 75%~90% to avoid the sharp temperature drop causing the sensation of freezing. The actuator nozzle diameter should be 0.2mm~0.3mm to produce a flow with relatively low mass flow rate. Furthermore the numerical model is capable of predicting the residual mass median diameter (MMD) of the spray, by using evaporation model of multicomponent liquid droplets, to quantify the sprays. Two different formulations with 95% and 98% mass fraction of HFA 134a, and two prototype cigarette alternatives with different expansion chamber volumes, have been analyzed by the numerical model and compared with the dual laser measurements. In addition, it considers the spray character by high speed imaging, with the special interest in the flashing phenomena and droplet sizes. It concludes that a larger expansion chamber volume enhances the propellant evaporation, recirculation, bubble generation and growth inside the chamber, and it made a significant improvement to produce finer sprays. Although the formulation with 98% of HFA 134a can generate smaller droplets, the formulation with 95% of HFA 134a produces more steady puffs with relatively low mass flow rate.
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16

Chen, Wei Jie. "Investigation of molecular dissolution mechanism of ketoprofen binary and ternary solid dispersions by molecular dynamics simulations." Thesis, University of Macau, 2017. http://umaclib3.umac.mo/record=b3690953.

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17

Chan, Teng Ian. "Investigating the molecular dissolution mechanism of binary solid dispersions by molecular dynamics simulations." Thesis, University of Macau, 2017. http://umaclib3.umac.mo/record=b3690969.

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18

Mourshed, Mona. "Technology transfer dynamics : lessons from the Egyptian and Indian pharmaceutical industries." Thesis, Massachusetts Institute of Technology, 1999. http://hdl.handle.net/1721.1/9321.

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Thesis (Ph.D.)--Massachusetts Institute of Technology, Dept. of Urban Studies and Planning, 1999.
Includes bibliographical references (leaves 139-142).
Over the past fifty years, development theorists have presented multiple explanations for why industrial technology transfer to developing countries is difficult. Although much progress has been made in identifying broad areas of transfer failure, concrete technology transfer policy lessons for firms and governments remain elusive. This dissertation examines the technology transfer challenges faced by firms in developing countries during intermediate industrialization. Using the Egyptian and Indian pharmaceutical industries as case studies, it undertakes two tasks. First, the study analyzes full-cooperation transfers to understand the obstacles encountered by three types of local and foreign pharmaceutical transfer partners (multinational drug headquarters and subsidiaries, equipment suppliers and buyers, and equipment manufacturing joint ventures). Second, the research examines no-cooperation transfers, and the experiences of local firms that learn pharmaceutical manufacturing skills by copying existing drugs on the world market. This part of the research>articularly focuses on how Egyptian and Indian drug firms are responding to an international patent agreement, TRIPs, that severely restricts the scope of their imitation activities. In the context of both the full-cooperation and no-cooperation cases, this dissertation empirically evaluates four main theories in the debate over why technology transfer to industrial firms in developing countries is difficult: (1) technological knowledge; (2) recipient characteristics; (3) transferor characteristics; and, (4) economic environment. This dissertation finds that the development literature provides incomplete explanations of firm transfer experiences and obstacles, and provides alternative conceptualizations of technology transfer dynamics during industrialization. First, codified technology transfers can be just as problematic as tacit ones, implying that a technology's knowledge characteristics are not directly correlated with transfer ease. Second, rather than transferors teaching recipients how to use technology, partners often work together to solve new problems that occur at the local site. Third, while transfer problems do revolve around technical issues, they are frequently precipitated by social issues, namely communication and rapport difficulties between partners. Fourth, contrary to widespread thinking, government industrial policy can be a positive force in technology transfer. By create a demanding home environment for local firms, the state can force firms to improve their technological capabilities, and to prepare themselves for global market competition.
by Mona Mourshed.
Ph.D.
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19

Tumuluri, Venkat S. "Quantitation of pharmaceutical formulations and monitoring of pharmaceutical processes using process analytical technology techniques : near infrared and Raman spectroscopy /." Full text available from ProQuest UM Digital Dissertations, 2007. http://0-proquest.umi.com.umiss.lib.olemiss.edu/pqdweb?index=0&did=1414121171&SrchMode=1&sid=7&Fmt=2&VInst=PROD&VType=PQD&RQT=309&VName=PQD&TS=1220637804&clientId=22256.

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20

Akane, Felix Oloniyon. "Multiple compression in tableting technology." Thesis, Liverpool John Moores University, 1996. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.337793.

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21

Qayyum, Imran 1971. "eBusiness technologies and trends in the pharmaceutical industry." Thesis, Massachusetts Institute of Technology, 2003. http://hdl.handle.net/1721.1/16997.

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Thesis (S.M.M.O.T.)--Massachusetts Institute of Technology, Sloan School of Management, Management of Technology Program, 2003.
Includes bibliographical references (leaves 121-124).
This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.
eBusiness is rapidly becoming the defacto business model of many firms. The pharmaceutical industry will continue to thrive regardless of recession, terrorism, war, or other external forces. Question is: what eBusiness technologies and trends are being currently pursued by pharmaceutical companies in managing critical relationships with business partners such as doctors, physicians, suppliers, retailers, distributors, and consumers? The purpose of this research is to provide a high-level overview of the pharmaceutical industry and companies that dominate in this vast arena. This is followed by an in-depth analysis of eBusiness in terms of phases, models, architectures, vendors, and products. Finally, eBusiness technologies and trends in global pharmaceutical organizations related to procurement, sales, and supply chain are analyzed in various case studies. This analysis ultimately leads to a carefully orchestrated conclusion that recaps this entire research based on eBusiness in the pharmaceutical industry.
by Imran Qayyum.
S.M.M.O.T.
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22

Smith, Peter J. A. (Peter John Anthony) 1959. "Organizational design : the integration of pharmaceutical discovery and development." Thesis, Massachusetts Institute of Technology, 2004. http://hdl.handle.net/1721.1/28588.

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Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology; and, (S.M.M.O.T.)--Massachusetts Institute of Technology, Sloan School of Management, Management of Technology Program, 2004.
Includes bibliographical references (leaves 60-61).
The decline in Pharmaceutical R&D productivity has been attributed to high clinical failure rates suggesting that targets, leads and clinical candidates may be of lower quality in recent years. Senior R&D management generally believes that a greater integration of drug discovery and development will improve the selection and optimization of clinical candidates. I demonstrate the different nature of discovery and development with discovery tasks seen as more uncertain, having more reciprocal work flows and more under the control of management than development tasks. Discovery and development personnel have different characteristics and motivations, with discovery staff having greater creative skills and development staff greater planning skill. Following a congruence approach to organization design these differences imply that a complete merging of discovery and development functions would lead to poor fit between organizational design elements. This leaves an ongoing requirement for integrative systems which can preserve the important characteristic of discovery and development functions yet provide knowledge integration at key decision points to improve the quality of clinical candidates. A wide range of integrating mechanisms was found to be in use with an emphasis on cross functional teams. Information Technology was viewed as necessary infrastructure but not an important component of knowledge integration. No strong links were found between pipeline maturity and the integrative mechanism deployed. I speculate that company R&D performance could be better matched to internal and external circumstances by a more active approach to managing integrative systems. I propose a conceptual model of integrative systems to guide a more dynamic management approach
(cont.) to organizational design of R&D and suggest further work to formalize the model through an agent based simulation.
by Peter J.A. Smith.
S.M.M.O.T.
S.M.
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23

Isaacs, Nasreen. "Formulation and process optimisation of ethionamide 250 MGtablets using quality by design principles." Thesis, Nelson Mandela Metropolitan University, 2015. http://hdl.handle.net/10948/3979.

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The traditional approach of Quality by Testing (QbT) limits the assurance of product quality to in-process and post-production testing. To overcome these limitations, a more proactive and systematic means to product development and optimisation is required. Quality by Design (QbD) is an example of such an approach which focuses on understanding the product and its manufacturing process and emphasises that quality should be built into the product and not merely tested. The study aims to optimise ethionamide tablets, an immediate release oral solid dosage form using QbD.
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24

Mansa, Rachel Fran. "Roll compaction of pharmaceutical excipients and prediction using intelligent software." Thesis, University of Birmingham, 2007. http://etheses.bham.ac.uk//id/eprint/5406/.

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Roll compaction is a dry granulation method. In the pharmaceutical industry it assists in binding tablet ingredients together to form a larger mass. This is conducted to ease subsequent processing, decrease dust, improve flowability, improve material distribution, more suitable for moisture and heat sensitive materials than wet granulation methods, minimises operating space and suited for a continuous manufacturing set-up. In pharmaceutical roll compaction various types of powder material mixtures are compacted into ribbon that are subsequently milled and tableted. The aim of this research is to investigate the use of intelligent software (FormRules and INForm software) for predicting the effects of the roll compaction process and formulation characteristics on final ribbon quality. Firstly, the tablet formulations were characterised in terms of their particle size distribution, densities, compressibility, compactibility, effective angle of friction and angle of wall friction. These tablet formulations were then roll compacted. The tablet formulation characteristics and roll compaction results formed 64 datasets, which were then used in FormRules and INForm software training. FormRules software highlighted the key input variables (i.e. tablet formulations, characteristics and roll compaction process parameters). Next these key input variables were used as input variables in the model development training of INForm. The INForm software produced models which were successful in predicting experimental results. The predicted nip angle values of the INForm models were found to be within 5%, which was more accurate to those derived from Johanson’s model prediction. The Johanson’s model was not successful in predicting nip angle above the roll speed of 1 rpm due to air entrainment. It also over-predicted the experimental nip angle of DCPA and MCC by 200%, while the approximation using Johanson’s pressure profile under-predicted the experimental nip angle of DCPA by 5-20% and MCC by 20%.
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25

Lee, Kai Teck. "Continuous granulation of pharmaceutical powder using a twin screw granulator." Thesis, University of Birmingham, 2013. http://etheses.bham.ac.uk//id/eprint/4002/.

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Twin screw extruder (TSE) has been studied extensively as a granulator because it allows continuous processing. Initial work was carried out by comparing the TSE with conventional granulator shows that the mechanism of TSE granulation is different from conventional granulation with the absence of the consolidation stage. PEPT was also utilised and it reveals that the flow stream of the material is not only due to the conveying capacity but also the granulator fill, in particularly for the 90o mixing zone which is believed to be a dispersion type of mechanism driven by the granulator fill gradient. Residence time distribution was measured and simulated by fitting the experimental data using a continuous stirred tank reactors model. The model describes the experimental curves reasonably well when a plug flow fraction was considered. Generally the mean residence time (MRT) of the system is proportional to the mixing zone angle and is inversely proportional to the screw speeds and flowrate. A study using the variance reduction ratio demonstrates that the TSE granulator used in the present study is able to remove the feed instability given that the ratio of the frequency of the input stream fluctuation to the MRT is high.
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26

Kundu, Jayeeta. "Cross-country study on the promotion of new pharmaceutical products." Thesis, Massachusetts Institute of Technology, 2006. http://hdl.handle.net/1721.1/34524.

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Thesis (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division, Technology and Policy Program, 2006.
Includes bibliographical references (p. 170-176).
Detailers are one of the most powerful components of pharmaceutical marketing. Drug manufactures spend a lion's share of their marketing budgets on their detailers, and with direct-to-consumer (DTC) marketing coming under closer scrutiny, it is likely that detailing will receive even more funding in the coming years. This thesis analyzes how differences in detailing regulations in the United States, United Kingdom, Sweden, Italy, and France lead to differences in the promotion and sales of antinausea, antihypertensive, and antipsychotic medications during the time period of 1992 to 2003. In order to determine if promotional efforts vary across generations of medications in the same therapeutic class, antinausea and antipsychotic medications are classified as new and old generations and antihypertensives are classified as new, middle, and old generations in this study. Qualitative and quantitative methods are used to examine population, economic, price, promotional, regulatory, and cultural factors that contribute to the sales of pharamaceutical products. The qualitative discussion includes an overview of all five sample countries' health care systems, health care policies, and the prevalence of hypertension, cancer incidence, and psychosis.
(cont.) Econometric tools are used to conduct the quantitative analysis. The effect on pharmaceutical sales and the diffusion of new generation pharmaceutical products is examined. Chow tests are conducted for cross-country differences. This study finds that there are significant cross-country differences in the diffusion of the three therapeutic classes in the five sample countries examined in this thesis. The different factors examined contribute to diffusion in varying extents in the five sample countries. Culture is found to play an important role in the sale and use of all three therapeutic classes, but an especially crucial role in the case of antipsychotics. The promotional factors appear to play a significant role in the diffusion of new generation products relative to older generation products, but are not found to have a statistically significant effect on the larger therapeutic level.
by Jayeeta Kundu.
S.M.
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27

胡元佳. "Pharmaceutical patent valuation based on technology innovation and applications in the industry." Thesis, University of Macau, 2009. http://umaclib3.umac.mo/record=b2150641.

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28

Muranishi, Hiroya 1964. "Technology acquisition strategies in pharmaceutical companies through equity investment, alliance and acquisition." Thesis, Massachusetts Institute of Technology, 2002. http://hdl.handle.net/1721.1/8469.

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Thesis (S.M.M.O.T.)--Massachusetts Institute of Technology, Sloan School of Management, Management of Technology Program, 2002.
Includes bibliographical references (leaves 120-121).
The pharmaceutical industry is now confronted with a discontinuous time period, especially in terms of its technology. In order to maintain their advantageous positions in the industry, pharmaceutical companies have to invest not only in internal R&D but also in external sources, since technologies in the industry are too broad to enable a company to cover all of the new technologies. Allotment of investment in internal and external R&D, however, is hard to determine; moreover, the selection of targets and styles of external technology acquisition by pharmaceutical companies requires deep deliberation on all the scientific and business aspects. In this thesis, I have analyzed the correlation between technology acquisition activities and the internal technological strength, or product development, in nine pharmaceutical companies in three countries: U.S., Japan, and Germany. Styles of technology acquisition deals vary among the three countries. German companies showed the most aggressive technology acquisition strategies in overall technology deals. U.S. companies exhibit strong technology acquisition strategies with prominent equity investment deals. Japanese companies were discreet about their technology acquisition deals, although they showed a similar degree of eagerness for product acquisition. The number of technology acquisition deals by Japanese companies, however, has increased during the past two or three years. A positive correlation between the number of all deals and product development (the number of pre-clinical drug candidates) was detected. On the other hand, there is no clear correlation between technology creation deals or technology frontier deals and product development. In order to assimilate the growing amount of external property, pharmaceutical companies must consider setting up an appropriate management organization because the deals between biotech enterprises and pharmaceutical companies involve dissimilar organizations in terms of culture, size, power, and expertise. I studied the organization of alliance management in Eli Lilly as an example.
by Hiroya Muranishi.
S.M.M.O.T.
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29

Brown, Stacy D. "Drug Testing: Technology, Tricks and the Two-Test System." Digital Commons @ East Tennessee State University, 2013. https://dc.etsu.edu/etsu-works/5259.

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30

Muller, Damian Christian. "Investigating the influences of validation on pharmaceutical manufacturing processes." Thesis, Nelson Mandela Metropolitan University, 2007. http://hdl.handle.net/10948/566.

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This investigation attempts to examine the influences of validation on pharmaceutical processes especially at a new manufacturing facility that has to meet international requirements, and fulfil a cost effective business strategy. At Aspen Pharmacare, a pharmaceutical organisation, there are two manufacturing facilities situated adjacent to each other, one new and one old. The new facility creates ideal opportunities to supply products to local and international markets. The investigation compares legal requirements from local and international regulatory authorities. Validation and qualification practices as well as the problems encountered during the different phases are discussed. Particular attention is given to the validation approach at the new Aspen facility. Problems and proposed solutions relating to the design review, installation, operational, and performance qualification are discussed. Validation of analytical methods for cleaning analysis, cleaning validation of equipment, and optimisation of some tablet manufacturing processes are described. Statistical evaluations of analytical results are included to find the optimum conditions for integrating new personnel with new processes and equipment. A business model reviews the cost of non-conformances of the enalapril maleate 10 mg tablets manufactured at the two manufacturing facilities. Finally the dissertation proves that validation is not only a regulatory requirement but that it also provides benefits such as adding value to the business, and ultimately reducing the cost of medicines.
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31

Corrigan, Damion K. "Analytical technology for cleaning verification and analysis of drug purity in pharmaceutical production." Thesis, Cranfield University, 2008. http://dspace.lib.cranfield.ac.uk/handle/1826/3483.

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Production of pharmaceuticals is a complex process which goes beyond the synthetic reactions undertaken to produce the final drug product. In multi purpose manufacturing facilities the equipment used in the processes must be proven to be sufficiently free of residue from the previous compound so that safe manufacture of the next compound can commence. Cross contamination can pose serious health risks so cleaning verification is a process of extreme importance. Pharmaceutical products may contain impurities that originate from the synthetic stages of production, the starting materials or from in situ reactions taking place in the final drug. Some of these impurities may be genotoxic. Genotoxic impurities are a class of impurities for which awareness is currently growing in the pharmaceutical industry. Traditional analytical chemistry methods such as HPLC are currently employed for the detection and quantification of cleaning residues and genotoxic impurities. These methods can be extremely time consuming. The aims of this project are to investigate swab sampling in cleaning verification, to develop alternative analytical methods which speed up and enhance knowledge of the cleaning verification process and to begin the development of an assay system for commonly occurring genotoxic impurities.
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32

Howard, Krystel S. "Process analytical technology investigation of the crystallization of pharmaceutical polymorphs, salts and hydrates." Thesis, Loughborough University, 2011. https://dspace.lboro.ac.uk/2134/8464.

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Pharmaceutical industries aim for continuous improvement in the manufacturing process of producing medicines. Demands on the pharmaceutical industries are to produce quality products in a quick and cost effective way. Designing a robust crystallization process so as to produce quality crystals with the desired polymorphic form, morphology, size and size distribution, will contribute towards meeting these demands. The Food and Drug Administration regulating body encourages the development of quality by design (QbD) approaches, involving the use of process analytical technology (PAT) for the design of the crystallization process. This method enables the design of the crystallization process to be more flexible in terms of variation in operating conditions and process parameters so long as the quality of the product is maintained. The aim of this thesis work is to use QbD approaches involving the use of PAT tools and solid state analytical (SSA) techniques to increase process knowledge and understanding, which is required for the robust design of crystallization processes. Discovery of all possible polymorphic forms of an active pharmaceutical ingredient (API) is important for the design of a robust crystallization process in which product quality is consistent during scale up and to prevent late stage failures. This thesis work shows the importance of using PAT tools and SSA techniques for monitoring polymorphic transformations and for the discovery of new polymorphic forms that have not yet been reported in the literature. A range of PAT tools including the FBRM, turbidity probe and ATR-UV/Vis spectrometer detected polymorphic transformations during both cooling and antisolvent crystallization experiments using the model system sodium benzoate in water and a propan-2-ol (IPA)/water mixture. Information obtained from a range of SSA techniques provided supporting evidence for the discovery of a new channel hydrate, channel solvate and an anhydrous form of sodium benzoate. The problem of crusting (solid depositing on vessel walls) occurring within crystallization vessels has been investigated with the use of a combination of PAT tools and SSA techniques. The FBRM and turbidity probe detected a change occurring during the cooling crystallization process of para-amino benzoic acid (ABA) in ethyl acetate. Repeats of the experiments using the ATR-UV/Vis confirmed that the change was due to crusting forming on vessel walls and not a polymorphic transformation. PAT tools also detected changes occurring during a pH controlled polymorphic cooling crystallization experiment (Chapter 9), which was subsequently confirmed by SSA methods to be due to the formation of a mixture of products and not a polymorphic transformation. This research work shows the importance of using a combination of PAT tools and SSA techniques for gaining a deeper understanding of the crystallization process and to prevent misinterpretation of results, saving both time and money. Also this research work highlights the need for improvement within industrial scale vessel design, such as vessels with variable jacket height, to prevent the problems of crusting. Robust MSZW measurements are obtained at laboratory scale using the model crystallization systems para and meta-ABA in water. PAT tools used include the FBRM and turbidity probe. The robust MSZW takes into consideration variation in process parameters including ramp rate, vessel size (1 mL and 1 L), agitator speed and type. This robust MSZW can be used for the design of scale up experiments (pilot plant and industrial scale), increasing the likelihood of producing a quality product. Nucleation orders used within crystallization models were determined from the MSZW measurements. Results showed that the nucleation order varied within different crystallization set-ups (vessel size and mixing conditions) using the model system meta-ABA in water. Therefore model-based design and scale-up of crystallization processes must be used carefully and more detailed mechanistic models, which take into consideration the effect of mixing need to be designed to improve the generality and applicability of crystallization models. pH controlled polymorphic crystallization experiments were performed using the model systems meta and para-ABA in ethanol and water. A combination of 5 PAT tools were used in a single vessel to monitor the cooling crystallization process. PAT tools used include FBRM, ATR-UV/Vis, PVM, pH and a temperature probe. Various parameters including mixing conditions, solvent, pH of solution, strength and type of acid were varied to investigate the best conditions to produce salts. Results showed that careful selection of design parameters and salt selection is important for producing quality crystals of the desired morphology so as to prevent problems in downstream processing.
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33

Nedwin, Glenn E. "Development of a business plan for a recombinant DNA technology based pharmaceutical company." Thesis, Massachusetts Institute of Technology, 1987. http://hdl.handle.net/1721.1/14846.

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34

Lagarde, Loïc (Loïc Jean Georges). "Exploring the future of the U.S. pharmaceutical industry : a supply chain perspective." Thesis, Massachusetts Institute of Technology, 2007. http://hdl.handle.net/1721.1/40294.

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Thesis (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division, Technology and Policy Program, 2007.
This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.
Includes bibliographical references (p. 76-80).
This thesis uses an innovative approach to explore the much-analyzed U.S. Healthcare system. To be sure, we are fully aware of the challenges involved in making robust system level policy recommendations and how local inefficiencies and hidden uncertainties undermine attempts proposing sweeping changes. Hence, we propose to investigate the Healthcare system using a supply chain perspective, which is inherently cross-functional and typically involves numerous different stakeholders. This holistic view will force us to think beyond artificial functional boundaries that promote local inefficiencies in the Healthcare system. Since the future is increasingly uncertain, we chose to use the scenario planning technique to guide the research process of developing effective system level policies. We will also leverage our insights to recommend new research directions to investigate the redefined system boundaries suggested by our scenarios. Since a Fortune 50 pharmaceutical company was used as a case study, the research focused primarily on a subset of the U.S. Healthcare system namely the U.S. pharmaceutical industry. The research also benefited from a series of workshops with supply chain executives from a variety of industries.
(cont.) These workshops helped us refine and validate the scenario planning methodology as a tool to think and plan for the long-term future in uncertain times. Furthermore, the analysis of U.S. Healthcare inefficiencies through a supply chain perspective resulted in some promising policy recommendations as well as exciting future research ideas.
by Loïc Lagarde.
S.M.
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35

Apshingekar, Prafulla P. "Applications of ultrasound in pharmaceutical processing and analytics." Thesis, University of Bradford, 2014. http://hdl.handle.net/10454/14127.

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Innovations and process understanding is the current focus in pharmaceutical industry. The objective of this research was to explore application of high power ultrasound in the slurry crystallisation and application of low power ultrasound (3.5 MHz) as process analytical technology (PAT) tool to understand pharmaceutical processing such as hot melt extrusion. The effect of high power ultrasound (20 kHz) on slurry co-crystallisation of caffeine / maleic acid and carbamazepine / saccharin was investigated. To validate low power ultrasound monitoring technique, it was compared with the other techniques (PAT tools) such as in-line rheology and in-line NIR spectroscopy. In-line rheological measurements were used to understand melt flow behaviour of theophylline / Kollidon VA 64 system in the slit die attached to the hot melt extruder. In-line NIR spectroscopic measurements were carried out for monitoring any molecular interactions occurring during extrusion. Physical mixtures and the processed samples obtained from all experiments were characterised using powder X-ray diffraction, thermogravimetry analysis, differential scanning calorimetry, scanning Electron Microscopy, dielectric spectroscopy and high performance liquid chromatography, rotational rheology, fourier transform infrared spectroscopy and near infrared spectroscopy. The application of high power ultrasound in slurry co-crystallisation of caffeine / maleic acid helped in reducing equilibrium time required for co-crystal formation. During carbamazepine / saccharin co-crystallisation high power ultrasound induced degradation of carbamazepine was negligible. Low power ultrasound can be used as a PAT tool as it was found to be highly sensitive to the changes in processing temperatures and drug concentration.
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36

Khan, Rehan A. (Rehan Abbas). "What future physicians want : a comparative analysis of the perception of medical students and pharmaceutical industry executives regarding the future of pharmaceutical sales." Thesis, Massachusetts Institute of Technology, 2007. http://hdl.handle.net/1721.1/42208.

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Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2007.
Includes bibliographical references (leaves 71-73).
The leading publicly traded pharmaceutical companies ("Big Pharma) in the US are facing a commercial crisis - their sales structure collectively consisting of more than 100,000 pharmaceutical sales representatives, originally setup to launch blockbusters, is suffering as a result of shrinking pipelines and low NME approvals. Although sales and marketing constitutes by far the largest corporate expense at 33% of revenues, sales productivity continues to decline. The goal of this study is to explore how pharmaceutical sales will change over the next 5 - 7 years and more specifically explore the role technology (including the internet) will play in the sales process. The study focuses on testing the perceptions of two key stakeholders -pharmaceutical executives and current medical students (future physicians) regarding the future of pharmaceutical sales process. Accordingly, 33 individuals were interviewed of which 18 were pharmaceutical executives and 15 were future physicians. The study tests three hypotheses: 1. Pharma executives believe that sales representative based detailing will continue to be the predominant method to engage and sell to physician customers while future physicians believe that technology will play a dominant role in the pharmaceutical detailing process. 2. Pharmaceutical executives agree that the most effective and ethical method to convey the benefits and challenges of an ethical pharmaceutical product are via a trained sales representative while future physicians believe that the sales representative does not effectively and ethically convey the merits of the relevant pharmaceutical therapy. 3. Person to person contact is not essential in conveying the merits of a particular ethical therapy - pharmaceutical executives disagree with this premise while future physicians agree.
(cont.) The data sets were compared using the following statistical tests: Yates' chi-square test, Armitage's chi-squared test and Two sample test of binomial proportions. In conclusion, the data showed that the perceptions of pharma executives and future physicians were in concurrence with each other.
by Rehan A. Khan.
S.M.
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37

Palm, Niklas. "Enhancement of short-term forecasts : A study of a pharmaceutical distributor." Thesis, Luleå tekniska universitet, Institutionen för ekonomi, teknik och samhälle, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:ltu:diva-62437.

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Forecasts are used to predict the uncertain outcome of a variable. These predictions are made to get an understanding of likely future scenarios which allows planning in advance. Forecasts are commonly used in inventory control systems to estimate the future demand. This estimation along with the estimated precision of the forecast can be used to determine adequate safety stocks. In extension, forecasts of the future demand can be used to support decisions regarding the replenishment of inventories.     This thesis involves forecasting of the demand of pharmaceutical drugs. In particular, drugs that are referred to as generics. The demand of generics can fluctuate heavily due to the substitution system and can therefore be troublesome to forecast. The main objective of this thesis is to design a suitable forecast approach for the demand of generics, and to examine how these forecasts can be used to control the replenishment of inventories. The project was executed at a pharmaceutical drug distributor and hopes to enlighten some new techniques that can be used to improve the handling of generics. To achieve the objective of this thesis, the initial focus was on the current state. The currently used methods where studied and compared with theories and methods described in literature. Assumptions and theories on which the currently used methods are based on could thus be identified. These assumptions where later assessed as either reasonable or unreasonable. Finally, a new forecast approach was designed to account for the insights gained from evaluating the current methods. The result of this thesis is a forecast approach suitable to forecast the demand of generics that account for the fluctuation in demand which occurs due to the substitution system. It assumes that the demand has a constant demand model, but an alternative method suitable for the trend model is also given. It is proposed that tracking signals are used to monitor the forecast such that systematic errors are identified. Furthermore, the literature review indicates that alternatives to the current method used to determine the reorder point should be considered for occasionally demanded generics.
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38

Chen, Xiao Jia. "Development of microscale separation techniques for quality control of Chinese medicines." Thesis, University of Macau, 2012. http://umaclib3.umac.mo/record=b2590374.

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39

Malhani, Mohammed Ali A. "Investigating Trends in the Adoption of CPOE System for Medication Orders and Determining Factors Associated with Meeting Meaningful Use Criteria for Health Information Technology." Thesis, Howard University, 2019. http://pqdtopen.proquest.com/#viewpdf?dispub=13419791.

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BACKGROUND: The 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act created meaningful use (MU) incentive program to promote the nationwide adoption of certified electronic health record (EHR) systems. Computerized physician order entry (CPOE) system is a part of the EHR system and a cornerstone of the MU incentive program, which helps to reduce prescribing errors and enhance care coordination for treatment between providers.

OBJECTIVES: The main objective of this study was to investigate trends in the adoption of CPOE system for medication orders and determine factors associated with meeting the meaningful use criteria for health information technology.

METHODS: A cross-sectional analysis was conducted using 10 years of data from the 2006–2015 National Ambulatory Medical Care Survey (NAMCS), 10 years of 2006–2015 data from the National Hospital Ambulatory Medical Care Survey (NHAMCS)—emergency department (ED) component, the 2016 American Hospital Association (AHA) Annual Survey Database, and the 2016 AHA Annual Survey Information Technology (IT) Supplement. The outcomes of the study included the adoption of CPOE for medication orders, drug-drug interaction alerts (DDI), guideline reminders, electronic prescribing (eRx), health information exchange (HIE), and compliance with the MU criteria. Descriptive statistics were calculated for all study variables. Bivariate analysis using the chi-square test was used to determine if there is a significant relationship between the adoption of CPOE for medication orders and timing (pre-post meaningful use). Chi-square test for trend was used to determine the significance of the change in the adoption of several EHR functionalities between 2006 and 2015. Logistic regression analyses were performed to identify factors that influence the adoption of several EHR functionalities. All analyses were performed using SAS 9.3 at an alpha of 0.05.

RESULTS: In NAMCS 2006–2015, the weighted surveyed physicians’ responses were weighted to represent 325,070 ambulatory based physicians throughout the U.S. The majority (66%) of respondents worked in group practices, and 34% worked as solo practitioners. The overall AHA annual survey sample had 6,239 hospitals. Of these, a total of 3,656 hospitals responded to the AHA IT supplement survey, representing a response rate of 59%. Primary care physicians’ adoption of CPOE systems for medication orders was significantly higher than specialists (p < 0.0001). The adoption of CPOE for medication orders was higher in the Post-MU incentive payments period (2012–2015) compared to pre-MU incentive payments period (2006–2011) in both the ambulatory care and ED settings (p < 0.0001). From 2006 through 2015 there was a statistically significant increase in the percent of ambulatory care practices adopting CPOE medication ordering system with clinical decision support (CDS) tools and eRx in the ambulatory care setting (p-trend < 0.001). In the same period, group practices compared to solo practices were significantly more likely to adopt these EHR functionalities (p < 0.0001). From 2013 to 2015, physician offices that generated > 50% of their revenue from Medicaid in the ambulatory care setting were less likely to adopt EHR systems that meet the MU criteria compared those generate ≤ 50% (p < 0.01).

CONCLUSION: Findings indicate that physician specialty, practice size, and percentage of revenue from Medicaid are significantly associated with the adoption of selected EHR functionalities. The CPOE for medication orders adoption rates significantly increased post-MU incentive payments. No significant association was found between for-profit hospitals and sending electronic notification to the patient’s primary care physician upon ED visit. These results may be important to design interventions to improve EHR adoption.

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40

Zeitler, J. Axel, and n/a. "Physical characterisation of pharmaceutical solids by terahertz pulsed spectroscopy and imaging." University of Otago. School of Pharmacy, 2007. http://adt.otago.ac.nz./public/adt-NZDU20070515.131938.

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Terahertz radiation refers to a specific part of the electromagnetic spectrum, flanked by microwave and infrared radiation at the higher and lower frequency end respectively. This thesis is about the development of applications using a new source of pulsed, coherent light for the physical characterisation of solids in the pharmaceutical setting. Terahertz radiation has excellent potential in the advancement of science but is, as yet, largely unexplored. Recent developments in semiconductor physics have made it possible to provide light at terahertz frequencies (a frequency of 1 THz equals a wavelength of 0.3 mm) in a relatively easy way. Light located in this range of the electromagnetic spectrum was very difficult to generate previously. It has unique properties in that it is possible to extract the full spectroscopic fingerprint of the materials by looking at the frequency response of the terahertz pulse. Here, vibrations of the whole molecule are probed rather than just the vibrations of single functional moieties within a molecules as is the case in infrared spectroscopy, which makes terahertz spectroscopy a very powerful tool for the analysis of the complex solid-state materials properties. In addition to structural information it easily penetrates through most plastics and polymeric materials used as excipients for pharmaceutical tablets. It is therefore especially useful for non-destructive imaging applications. At the example of polymorphic phase transitions, dehydration processes and crystallization experiments from the amorphous phase the potential of terahertz spectroscopy for pharmaceutical analysis was systematically investigated. In addition, a novel concept for using terahertz radiation in structural imaging of pharmaceutical dosage forms was developed. The technology, thus far predominantly used for the analysis of inorganic materials and semiconductors in particular, is now mature enough for its application to a wider field and to help with the understanding of fundamental and exciting new challenges at the interface between physics and the life sciences. Together with a comparison of this new technology to the established techniques in physical characterisation an initial attempt to understand and interpret the spectral information provided is presented. The potential for future applications is discussed.
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41

Srinivasan, Asvin. "Application of information technology and statistical process control in pharmaceutical quality assurance & compliance." Thesis, Massachusetts Institute of Technology, 2011. http://hdl.handle.net/1721.1/66047.

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Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Electrical Engineering and Computer Science; in conjunction with the Leaders for Global Operations Program at MIT, 2011.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 65-66).
Recently, the FDA issued new quality guidelines (Q10) encouraging drug manufacturers to improve their quality monitoring procedures. This renewed focus on quality and risk management has prompted Novartis to re-evaluate their systems and procedures to ensure compliance with the proposed guidelines. The company has chosen to respond by introducing more advanced statistical analysis of the data they share with regulatory bodies through the Annual Product Review (APR). However, procedural changes alone cannot bring about the needed innovation. Currently, too much time is spent on data consolidation and other non-value added tasks allowing less time for analysis. The solution is an Information Technology system with new procedures that will both improve process quality and increase productivity. The design proposed in this thesis utilizes statistical software that can analyze data securely, automatically generate graphs, and display alerts through an online dashboard. This Decision Support System will be integrated into Novartis's Global APR Automation project which aims to automate the generation of the entire APR document. A dashboard feature will allow processes to be monitored continuously instead of annually. The final version of the system will also include content management systems, business warehousing, audit validation and business intelligence tools. In addition to software, alternate statistical methods are proposed for evaluating critical processes that are either not in statistical control or lack normal distributions. These methods together with the new IT tools should help Novartis address process exceptions and reduce process variation without overloading the organization.
by Asvin Srinivasan.
S.M.
M.B.A.
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42

Chi, Zhilong. "Prospects for the application of advanced oxidation technology in the treatment of pharmaceutical wastewaters." Магістерська робота, Kyiv National University of Technology and Design, 2021. https://er.knutd.edu.ua/handle/123456789/19251.

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Advanced Oxidation Technology based on persulfate activation is an important part of advanced oxidation technology for water treatment, in which catalyst plays a very important role. In this master's thesis, LaCoO3/g-C3N4 catalyst was prepared by hydrothermal method and the catalytic degradation efficiency of LaCoO3/g-C3N4 catalyst for pharmaceutical wastewater was investigated, and the relationship between catalyst structure and degradation efficiency in catalytic activation of PMS was discussed. Based on the study of catalytic activated PMS oxidative degradation kinetic characteristics, investigation of reaction influencing factors and analysis of reaction mechanism, the synergistic enhancement effect and practical application value of various LaCoO3/g- C3N4 catalysts for PMS oxidation were discussed. The catalyst was characterized by XRD, XPS, FTIR, Raman and BET. Tetracycline hydrochloride was used as a typical and targeted contaminant in pharmaceutical wastewater, and the degradation performance of tetracycline hydrochloride by PMS activation of different catalysts was investigated. At the same time, the effects of different reaction conditions (PMS concentration, TC concentration, reaction temperature, pH, etc.) on the TC degradation performance of LaCoO3/g-C3N4 catalyst were studied.
Удосконалена технологія окислення, заснована на персульфатній активації, є важливою частиною передової технології окислення для обробки води, в якій важливу роль відіграє каталізатор. У цій магістерській дисертації каталізатор LaCoO3/g-C3N4 було виготовлено гідротермальним методом та досліджено ефективність каталітичної деградації каталізатора LaCoO3/g-C3N4 для фармацевтичних стічних вод, а також обговорено взаємозв’язок між структурою каталізатора та ефективністю деградації при каталітичній активації PMS. На підставі вивчення кінетичних характеристик окислювальної деградації каталітично активованого ПМС, дослідження факторів впливу на реакцію та аналізу механізму реакції, обговорено синергетичний ефект посилення та практичне застосування різних каталізаторів LaCoO3/g- C3N4 для окислення ПМС. Каталізатор був охарактеризований XRD, XPS, FTIR, Raman і BET методами. Тетрацикліну гідрохлорид застосували як типовий та цільовий забруднювач фармацевтичних стічних вод, та було досліджено ефективність деградації тетрацикліну гідрохлориду за допомогою PMS-активації різних каталізаторів. Водночас досліджено вплив різних умов реакції (концентрація ПМС, концентрація ТК, температура реакції, рН тощо) на ефективність деградації ТС каталізатора LaCoO3/г-C3N4.
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43

Chen, Chien-Chih. "Controlled Flow Cavitation Technology For Use In Pharmaceutical Processing Applications And Its Commercialization Plan." Case Western Reserve University School of Graduate Studies / OhioLINK, 2012. http://rave.ohiolink.edu/etdc/view?acc_num=case1339184669.

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44

Sih, Roderick Peng Tze Chemical Sciences &amp Engineering Faculty of Engineering UNSW. "New process development of dense gas technology for the processing of pharmaceuticals." Publisher:University of New South Wales. Chemical Sciences & Engineering, 2008. http://handle.unsw.edu.au/1959.4/41257.

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Drug re-engineering is an effective method for engineering existing products in alternative dosage forms and with enhanced pharmacokinetics. Insulin for the management of diabetic symptoms is an ideal candidate for re-engineering. Current subcutaneous therapy results in low patient compliance and is ineffective in meeting the physiological need for post-prandial insulin. Implementation of dose titration for more efficient blood-glucose management is also inconvenient and uncomfortable. Inhaled insulin is presented as a superior alternative to current therapy. The lungs offer excellent access to the circulatory system. Aerosols suspended in inspired air may deposit on lung epithelia and be available for systemic absorption. To evade the defense mechanism of the human respiratory tract, particle sizes have traditionally been minimized to achieve necessary aerosol performance. Recent developments indicate that more efficient performance augmentation may also be achieved by decreasing the bulk density of powders and modifying surface characteristics. Light and fluffy powders with rough surfaces experience much higher drag forces within an airstream. The Atomized Rapid Injection for Solvent Extraction (ARISE) process is a unique precipitation platform devised by incorporating a rapid injection technique for energetic solution delivery into supercritical fluid (SCF) media to effect recovery of previously dissolved pharmaceutical compounds. The quasi-instantaneous delivery of solutions alleviates the drawbacks of the use of capillary nozzles or micro-orifices, gradual elution and mixing controlled precipitation kinetics in existing SCF precipitation techniques. Most importantly, the energetic release of solution into SCF media effects supersaturation over a much larger spatial volume and promotes the homogeneous precipitation of low bulk density powders. ARISE processed insulin powders displayed characteristics that were highly influenced by anti-solvent conditions and powders of different qualities were obtained as a function of anti-solvent pressures. At lower anti-solvent pressures, powders of narrow particle size distribution were achieved, an indication of homogeneous supersaturation levels within processing. Span, the index of size distribution was as low as 0.991. At higher anti-solvent pressures, supersaturation rates were increased while mixing efficiencies decreased, resulting in powders of wider size distribution, and powder bulk densities as low as 0.01 g/ml. Low bulk density insulin displayed in-vitro respirable fractions as high as 78%.
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45

Johansson, Marcus. "Identification of the main factors influencing an RFID implementation in the automotive and pharmaceutical industries." Thesis, Linköping University, Department of Science and Technology, 2005. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-2886.

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This is a result of a master’s thesis project initiated by Stralfors BA Labels in Gothenburg. The purpose of the thesis is to identify the main factors influencing implementation of radio frequency identification, RFID, in the automotive and pharmaceutical industries. These factors are thereafter analyzed and concretized to provide Stralfors BA Labels with a better understanding of present and future business opportunities provided by the RFID technology in these two industries.

The thesis is focusing on applications of RFID that are related to supply chain management applications, and a theoretical framework on this subject is therefore included. The technology of RFID is described, analyzed and compared to barcodes, which is the prevalent technology used for product identification today.

RFID can be used in varied forms in both the pharmaceutical and automotive industry, based on the characteristics of the RFID technology we have chosen to divide possible RFID solutions in open system and closed loop system. In an open system the tags are discarded after they have passed through the supply chain and in the closed loop scenario the tags are reused and moved through the same processes of the supply chain multiple times.

We believe that the main factor for an RFID implementation in the pharmaceutical industry is the recommendations and potential mandates from the FDA to attach RFID tags on every pharmaceutical product that enters the U.S. pharmaceutical market, thus forming an open system. In the automotive industry we believe that the main use of RFID in the near future will be in closed loop solutions for instance to improve asset management. There are already pilot projects running and many of these projects indicate extensive benefits from the use of RFID. Implementation of RFID in open systems is delayed by technological immaturity, profitability concerns and a still on-going standardization process.

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46

Alspaugh, Jonathan D. (Jonathan Douglas). "The effects of licensing and equity financing cycles on pharmaceutical development." Thesis, Massachusetts Institute of Technology, 2011. http://hdl.handle.net/1721.1/68461.

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Abstract:
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2011.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 30).
The purpose of this paper is to examine the interactions between licensing status, equity issuance cycles, and drug development success at the small pharmaceutical companies that originate these development projects. Specifically, this paper is aimed at identifying how financing alternatives available to small pharmaceutical companies influence development success and firm behavior. The hypotheses developed and tested in this paper are as follows: H 1: Pharmaceutical development projects that are licensed are more likely to advance to the next stage in the clinical development process. H2: A licensed pharmaceutical development projects' likelihood of advancing to the next stage of the clinical development process will depend on the amount of equity issuance during the period in which the project was licensed. H3: Pharmaceutical development projects that are licensed during periods of low equity issuance are more likely to advance to the next stage in the clinical development process than projects that were not licensed or were licensed but not in a low equity issuance period. H4: Pharmaceutical development projects that originate at firms that have multiple projects in development at the beginning of a particular clinical trial stage are less likely to advance from phase I to phase II, but more likely to advance in later stages. H5: Pharmaceutical development projects that originate at firms that have previously launched a project in the market are more likely to be launched in the market. The results of a logistic regression analysis suggest that drugs licensed in periods of lowest equity issuance exhibit a higher rate of advancement from phase II to phase III. The relationship between advancement and amount of equity issuance at the time of licensing suggests that the lower the equity issuance in the licensing period the more likely the drug will advance. These results point to the possible existence of a "lemons" phenomenon in the market for pharmaceutical development projects. However, a different interpretation of the results suggests that large pharmaceutical company licensees are superior evaluators of quality and are perhaps more selective and opportunistically license higher quality drugs when equity issuance is low and licensors have no other financing options. Both interpretations point to the issue of information asymmetry as a central theme to this work.
by Jonathan D. Alspaugh.
S.M.
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47

Ananieva, V. V., S. О. Petrov, and D. S. Goloborodko. "Search of new excipients in technology of farmaceutical drugs." Thesis, Національний технічний університет "Харківський політехнічний інститут", 2018. http://repository.kpi.kharkov.ua/handle/KhPI-Press/45931.

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48

Randall, Tina S. (Tina Sofia) 1972. "Analysis of the introduction of new technologies to evaluate the performance of pharmaceutical unit operations." Thesis, Massachusetts Institute of Technology, 1998. http://hdl.handle.net/1721.1/9930.

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49

Pooni, Gurkanwal Singh. "The creation and development of technology by MNEs within the chemical, pharmaceutical and biotechnology industries." Thesis, University of Reading, 2001. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.393242.

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50

Freilich, Jonatan. "When Innovation Is Not Enough : Managerial Challenges of Technology Change in Pharmaceutical R&D." Doctoral thesis, KTH, Industriell Management, 2015. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-176484.

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Abstract:
Innovation is not always enough. In the beginning of the 2000s established pharmaceutical firms had developed several drugs, yet these new products were far too few. Patents of many blockbuster drugs were to soon expire and substantial profit would then be lost. A potential solution emerged: implementing new biomarker technologies in drug development. Biomarkers are required for knowledge creation about the drug effect on underlying causes of a disease. The problem is this: although academia, industry, and policy makers have deemed biomarkers as necessary for successful drug development, pharmaceutical firms have not used them in actual drug development projects.  Since the 1990s, established pharmaceutical firms have invested financially and restructured organizationally in order to implement biomarkers. Still, cases show that more than 50% of project termination in Clinical Phase 2 (the bottle neck of drug development) can be attributed to the lack of implementing biomarkers.   Challenges of established firms transforming in the face of technology change is a commonly studied phenomenon within innovation management literature. Several explanations have attempted to determine why established firms fail in following technology change. However, most of this literature has been based upon an empirical context where technology change is conceptualized as an innovation of the dominant product design in the industry. Consequently, the challenge is to develop or adapt a discontinuous product innovation. Conversely, implementing biomarkers is a case of technology change that impacts R&D. Since drugs lose their value when the patent protection expires, the established pharmaceutical firms need to continuously develop new block buster drugs – not just one product. More research is needed to fill this gap in the literature in order to develop an understanding of the established firm challenge in implementing biomarkers. This thesis builds upon a longitudinal case study of AstraZeneca. Using multiple data sources, the findings show that the dominant architecture of the drug development process during the 2000s impeded the implementation of biomarkers. AstraZeneca required an “architectural process innovation” in order to complete this implementation. The company’s process-based management structures distorted it from recognizing the need for process change. This thesis has three contributions: First, it describes the process change and the firm’s managerial challenges associated with biomarker implementation; Second, it contributes to the literature on the established firm challenge by developing an understanding of the phenomenon of architectural process innovation; Third, it develops a process-based framework for studying technology change that affects R&D.

QC 20151106

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