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Li, Hoi-kwong. "Filing of complaints by the US Food and Drug Administration /". View the Table of Contents & Abstract, 2005. http://sunzi.lib.hku.hk/hkuto/record/B35082471.
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Li, Hoi-kwong, i 李海光. "Filing of complaints by the US Food and Drug Administration". Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2005. http://hub.hku.hk/bib/B45010766.
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Lamb, James Alexander. "Under-reporting of Adverse Drug Reactions to the Food & Drug Administration". ScholarWorks, 2018. https://scholarworks.waldenu.edu/dissertations/6055.
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This study examined the potential significant differences in the distribution of adverse drug reactions (ADRs) by reporter (consumer versus physician) and patient outcome at case and event level. This study also contains exploratory questions to evaluate reporting of ADRs by consumers versus physician by system organ class (SOC) and reporter demographics within the United States Food & Drug Administration Adverse Event Reporting System (FAERS). The theoretical foundation applied in this quantitative study was the social amplification of risk framework. Data from the second quarter of 2016 were obtained from FAERS, and a total of 87,807 ADR reports corresponding to 143,399 ADRs were analyzed by utilizing the chi-square test, the odds ratio, and logistic regression. Cross-sectional design was employed to compare reporting of ADRs at the case and event level (case-based and event-based analyses, respectively) between reporters (consumer versus physician), specifically, for patient outcome, as well as SOC and reporter demographics. For both the case-based and event-based analyses, findings revealed that consumers reported more serious ADRs in comparison to physicians. Furthermore, findings confirmed a difference in ADR reporting between consumers and physicians depending on SOC groups. Additionally, consumers reported more nonserious ADRs in comparison to physicians. The results from this study may have implications for positive social change by augmenting pharmacovigilance systems at a national and international level to identify risks and risk factors spontaneously reported after drugs have been on the market.
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Wang, Bo. "Clinical Evidence Supporting Pharmacogenomic Biomarker Testing Provided in US Food and Drug Administration Drug Labels". Thesis, Harvard University, 2016. http://nrs.harvard.edu/urn-3:HUL.InstRepos:27007749.
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Background: Genetic biomarkers that predict a drug’s efficacy or likelihood of toxicity are assuming increasingly important roles in the personalization of pharmacotherapy, but there is concern that there may be insufficient evidence linking use of some biomarkers to clinical benefit. Nevertheless, information about the use of biomarkers appears in the drug label for many prescription medications. This may add confusion to the clinical decision-making process.
Objective: To evaluate the evidence supporting pharmacogenomic biomarker testing in drug labels, how frequently testing is recommended, and completeness of citation of the supporting studies.
Methods: We used publicly-available databases from the US Food and Drug Administration (FDA) to identify drug labels that described the use of a biomarker and evaluated whether the label contained or referenced convincing evidence of its clinical validity (i.e., the ability to predict phenotype) and clinical utility (i.e., the ability to improve clinical outcomes) using guidelines published by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) group. We graded the completeness of the citation of supporting studies and determined whether the label recommended incorporation of biomarker test results in therapeutic decision-making.
Results: Of the 119 drug-biomarker combinations, only 36% (n=43) had labels that provided convincing clinical validity evidence while 15% (n=18) provided convincing evidence for clinical utility. Fifty-one percent of the labels (51%, n=61) made recommendations based on the results of a biomarker test; 30% of these contained convincing clinical utility data. A full description of supporting studies was included in 11% (n=13) of the labels.
Discussion: Fewer than one-sixth of drug labels contained or referenced convincing evidence for clinical utility of biomarker testing while over half made recommendations based on biomarker test results. It may be premature to include biomarker testing recommendations in drug labels when convincing data linking testing to patient outcomes does not exist.
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Richert, Lucas. "Pills, politics, and pitfalls : The food and drug administration during the Reagan years". Thesis, University of London, 2010. https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.536790.
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Mayhew, Brian Michael. "An evaluation of the food and drug administration’s expedited pathways". reponame:Repositório Institucional do FGV, 2016. http://hdl.handle.net/10438/17995.
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Biopharmaceutical development is characterized by challenging regulations, intense competition and significant costs that result in the need for biopharmaceutical companies to consistently produce innovation biopharmaceutical products. The United States Congress has sought to provide a balanced environment that combines significant regulatory oversight by the US Food and Drug Administration (FDA) with market-based incentives (patent protection, exclusivity) and expedited pathways (accelerated approval, breakthrough designation, fast track designation, and priority review) that seek to quickly identify and move innovative new medicines through development that will address unmet medical need and treat serious or life-threatening diseases or conditions. While FDA’s expedited programs are believed to accelerate the development of innovative drug products, the programs have not been formally measured against their intended purpose: more efficient development and regulatory reviews. This thesis research project attempts to effectively measure FDA’s expedited programs by cataloguing FDA approvals from 1987-2015, measuring development and regulatory review time, and drawing conclusions and making recommendations based on the statistical analyses generated from the project.
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Garmendia, Craig A. "Patterns of Regularity Noncompliance Identified by the U.S. Food and Drug Administration and Their Effects on Meta-analyses". FIU Digital Commons, 2018. https://digitalcommons.fiu.edu/etd/3920.
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The objective of this study was to determine the patterns of regulatory noncompliance, as identified by the U.S. Food and Drug Administration (FDA), and their effects on meta-analyses. In order to achieve these objective, three studies were undertaken: analysis of citations issued by FDA Investigators at the conclusion of an inspection; analysis of regulatory actions taken by the FDA towards clinical researchers based on the observations cited by FDA Investigators; and sensitivity analysis of meta-analyses based on the Agency’s determination of research misconduct, primarily the falsification of data. FDA Investigator citations were analyzed using Chi-Square analysis based on geographic location of the inspection, type of inspection, and type of violation. Temporal changes in the number of inspections and the violations cited were analyzed using bivariate Poisson regression models. Bonferroni correction was employed for temporal changes across the time period analyzed. Regulatory actions taken by the agency were analyzed via Chi-Square or Fisher’s exact test based on changes identified in previous publications, temporal changes, and differences between regulatory action types. Sensitivity analysis of meta-analyses identified through a systematic review were assessed both qualitatively and quantitatively for the effects of including publications of apixaban trials with significant FDA regulatory action, i.e. the comparison of odds ratio point estimate, upper and lower 95% confidence interval, both before and after consideration of falsified data.
Under the FDA’s Bioresearch Monitoring program from 2007-2015, the number of inspections increased, but the rate of citation issuance per inspection decreased. One third of the violations were related to adherence to investigational procedures followed by informed consent violations and violations involving study records. During this same time period, 194 clinical researchers received a regulatory action based on FDA’s review of inspection results. Since 2007, rates of significant deviations had decreased. Lack of researcher supervision and submission of false information were cited more frequently for disqualification proceedings. A systematic review found 99 statistical analyses from 22 different meta-analyses available for sensitivity analyses. Nearly one-third resulted in a change in the conclusions reported in the originally published statistical analyses.
In approximately the last decade, the number of violations cited during inspections under the Bioresearch Monitoring program has decreased; however, significant improvements can continue to be made regarding adherence to study procedures, the consenting of human subjects, and creation of adequate and accurate study documentation. Disqualification of clinical researchers is more likely to occur when researchers fail to supervise a clinical trial or false information is submitted to the FDA. Falsified data can make its way into the exploding field of meta-analyses, a study method that provides a concise and compelling method for the dissemination of medical intervention knowledge; however, this method can be highly unstable and can provide biased results. A robust sensitivity analysis that considers data quality from available sources can help ensure calculations of the best estimates.
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Balmaceda, Zaira, i Kathy Lin. "Comparison of Findings from Published Weight Loss Trials for Orlistat to the Findings Used by the Food and Drug Administration (FDA)". The University of Arizona, 2010. http://hdl.handle.net/10150/623796.
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Class of 2010 AbstractOBJECTIVES: The objective was to compare differences in weight loss data presented in published orlistat studies on orlistat to their corresponding studies submitted to the FDA. METHODS: This meta-‐analysis compared one-‐year weight loss data reported in six published orlistat 120 mg studies to data reviewed by the FDA in the New Drug Application (NDA). The primary dependent variables were the percentage of subjects achieving 5% and 10% weight loss. Prior to analysis, weight loss data was stratified into placebo and orlistat groups. Potential for bias was assessed with a funnel plot and by calculating Kendall’s tau. The a priori alpha level was 0.05. RESULTS: Corresponding FDA reviews were located for 6 published orlistat trials. The pooled odds ratio of published vs. FDA 5%weight loss data for the placebo arm was 2.18 (95% CI: 1.83 to 2.60; p < 0.001) and 1.95 (95% CI: 1.70 to 2.24; p < 0.001) for the orlistat arm. The pooled odds ratio of published vs. FDA for 10% weight loss data for the placebo arm was 2.25 (95% CI: 1.74 to 2.91; p < 0.001) and 2.20 (95% CI: 1.88 to 2.57; p < 0.001) for the orlistat arm. The p-‐values for Kendall’s tau for the 5% and 10% weight loss data were 0.054 and 0.34, respectively. CONCLUSIONS: Published orlistat trials presented 5% and 10% weight loss data that were twice of that reported in the FDA-‐reviewed trials, and there was potential for bias in the 5% weight loss data.
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Noh, In Joon. "Essays on Drivers of Quality and Compliance Performance in the Pharmaceutical Industry: Policy, Manufacturing Strategy, and Organizational Learning Perspectives". The Ohio State University, 2020. http://rave.ohiolink.edu/etdc/view?acc_num=osu1595014194719331.
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Barrett, Jane A. "Applying strategles of architectural androgeny to a renovation of and addition to an existing building currently occupied by the food and drug administration". Thesis, Georgia Institute of Technology, 1994. http://hdl.handle.net/1853/23446.
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Chen, Yan. "Comparisons and applications of quantitative signal detections for adverse drug reactions (ADRs) an empirical study based On The food And drug administration (FDA) adverse event reporting system (AERS) and a large medical claims database /". Cincinnati, Ohio : University of Cincinnati, 2008. http://www.ohiolink.edu/etd/view.cgi?acc_num=ucin1203534085.
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Thesis (Ph.D. of Pharmacy Practice and Administrative Sciences)--University of Cincinnati, 2008.Advisor: Jeff Guo PhD. Title from electronic thesis title page (viewed May 9, 2008). Keywords: data mining algorithms; adverse drug reactions; adverse event reporting system; signal detection; case-control study; antipsychotic; bipolar disorder. Includes abstract. Includes bibliographical references.
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CHEN, YAN. "Comparisons and Applications of Quantitative Signal Detections for Adverse Drug Reactions (ADRs): An Empirical Study Based On The Food And Drug Administration (FDA) Adverse Event Reporting System (AERS) And A Large Medical Claims Database". University of Cincinnati / OhioLINK, 2008. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1203534085.
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Ljungberg, Ida, i Amanda Martvall. "Lämpliga material för textila kärlimplantat : Kartläggning av kliniskt dokumenterade alternativ". Thesis, Högskolan i Borås, Akademin för textil, teknik och ekonomi, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:hb:diva-23511.
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En tredjedel av alla bypass-operationer leder till att kärlimplantaten slutar fungerar inom ettårs tid. En anledning till detta är bildandet av ogynnsam vävnad som sker i form av ärrbildning efter implantationen. Ärrvävnaden orsakar nya förträngningar vilket leder till ett försämrat blodflöde. Kärlimplantatet Y-graft har genom sin design som följer Murray´s lag, en naturlig blodflödesfördelning. Designen i form av ett Y har kunnat bekräftas vara fördelaktig då geometrin vid utflödet minskar risken för ärrbildning. Vad som saknas för att Y-graft ska kunna komma ut på marknaden är ett lämpligt material. Med detta som bakgrund uppkom syftet med litteraturstudien att undersöka vilka material meddokumenterad klinisk historik som är möjliga att använda vid textil tillverkning av Y-graft. Genom en gedigen litteratursökning med hjälp av sökverktyg som U.S. Food and Drug Administration (FDA) tillsammans med andra databaser inom de medicinska och materialtekniska områdena, har en förståelse skapats kring vilka material som används i medicintekniska produkter och som är möjliga kandidater till Y-graft. Litteraturstudien resulterade i att materialen polyetentereftalat, polybutentereftalat, polybutester polytetrafluoreten, polyester-, polyeter- och polykarbonatbaserade polyuretaner samt polypropen, polyeten, alfatisk polyamid och silke finns i godkända medicintekniska produkter på den amerikanska marknaden. De presenterade materialen har på så visdokumenterad klinisk historik och är lämpliga kandidater att använda vid textil tillverkning av Y-graft. De godkända materialkandidaterna som presenteras kan även beläggas medbiologiska polymerer för förbättrad biokompatibilitet. Materialkandidaterna har godkänts i medicintekniska produkter av U.S. Food and Drug Administration (FDA). Genom godkännandet har alla de presenterade materialen dokumenterad klinisk historik och är där med lämpliga kandidater att använda vid textiltillverkning av Y-graft.One third of all bypass surgeries causes vascular implants to stop working within a year. A reason for this is the formation of unfavorable tissue that occurs in the form of scarring after implantation. The scar tissue causes new constrictions, which leads to impaired blood flow. The vascular implant Y-graft, by design follows Murray's law and therefore has a natural blood flow distribution. The design in the form of a Y has been confirmed to be advantageous. The Y geometry at the outflow reduces the risk of scarring. What is missing for Y-graft to be able to enter the market is a suitable material. With this as a background, the purpose of the literature study was to investigate which materials with documented clinical history can be used in textile production of Y-graft. Through a thorough literature search, using search tools like the U.S. Food and Drug Administration (FDA) together with other databases in the medical and material engineering fields, an understanding has been created about which materials are used in medical technology products and which are potential candidates for Y-graft. The literature study concluded that the materials polyethylene terephthalate, polybutheneterephthalate, polybutester polytetrafluoroethylene are found in approved medical technology products in the United States. Polyester, polyether and polycarbonate based polyurethanes and polypropylene, polyethylene, alphatic polyamide and silk are also found in the United States medical market. These presented materials thus have documented clinical history and are suitable candidates for use in textile manufacturing of Y-graft. The approved material candidates presented can also be coated with biological polymers for improved biocompatibility. The material candidates have been approved in medical technology products by the U.S. Food and Drug Administration (FDA). With this approval, all the presented materials have documented clinical history and are therefore suitable candidates to use when manufacturing Y-graft.
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Yuan, Hsiu-Chun. "Optimising written medicine information for prescription medicines". Thesis, University of Sydney, 2020. https://hdl.handle.net/2123/23676.
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Optimising written medicine information for prescription medicines Aims: to improve the current and recently revised Australian Therapeutic Goods Administration (TGA) Product Information for prescription medicines (AUS-PI and TGA-AUS-PI, respectively) and recommend a PI format for the future. All current AUS-PI are expected to adopt the revised TGA format by the end of 2020. Methods: The overall study consisted of 3 stages – needs analysis (qualitative interviews with pharmacists n=16, GPs n=9), user testing with HCP students, and user testing with HCPs. Five rounds of face-to-face user-testing interviews were conducted to iteratively evaluate and re-design the TGA-AUS-PI for a prescription medicine – 3 rounds (n=11 per round) with healthcare professional (HCP) students (pharmacy n=25, dentistry n=5, medicine n=3) (Stage 2); and 2 rounds (n=10 per round) with HCPs (pharmacists n=16, GPs n=4) (Stage 3). An electronic version was also developed and evaluated in Stage 3. Results: Findings of the needs analysis (qualitative study) demonstrated that the current AUS-PI and the revised TGA-AUS-PI did not meet the needs identified by HCPs in terms of location and order of information, and design and readability of the content. In stage 2, an existing TGA-AUS-PI was first evaluated through an iterative process of user testing and the findings from the 1st round, as well as the participant recommendations from the needs analysis, and principles of good information writing and design were used to improve the TGA-AUS-PI. The improved AUS-PI was further evaluated and improved in two rounds of user testing to ensure that the final version was able to adequately communicate the key medicines information to the participants. Overall, significant improvements were made to the TGA-AUS-PI, with the exception of two sections (related to therapeutic indications and contraindications) which needed further work. In the final stage of the study, the TGA-AUS-PI was further redesigned and improved to address the outstanding issues from stage 2, with the evaluation being conducted by practising pharmacists and physicians. By the final user testing round, the study finalized AUS-PI (F-AUS-PI) (electronic and hard-copy versions) effectively communicated the key medicines information to the HCPs and the HCP considered the F-AUS-PI a much preferred document to use during consulting, prescribing and dispensing responsibilities with their patients. The overall main issues in the PI that required changing during both user testing stages were; complex and/or technical wording, disorganized categorization and arrangement of information, and inadequate application of the principles of good information writing and design. Conclusion: In this study, we were able to revise the TGA-AUS-PI (AUS equivalent of SmPC) so that the document was better able to communicate key medicines information to its intended audience, health care professionals. We were able to do this through a process of needs analysis, document design using principles of good writing and design, and iterative rounds of user testing evaluation and revision. Our recommendations for an improved TGA-AUS-PI format based on the study findings are to include: a summary information section, a table of contents, concise and succinct information, and information sections organized in the order of HCP perceived importance with least perceived important information such as clinical trials section at the end or as a separate document. Given that the primary use of the PI for HCPs is to use it as an on the spot, quick reference, the ability to locate and understand medicine information quickly is critical. Although, the changes and improvements were specific to the TGA-AUS-PI, the findings are applicable and can be utilized in the EU SmPC (especially the TGA-AUS-PI’s format appears to directly follow the SmPC format) and US-PI.
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Tang, Huaxiu. "Detecting Adverse Drug Reactions in Electronic Health Records by using the Food and Drug Administration’s Adverse Event Reporting System". University of Cincinnati / OhioLINK, 2016. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1470753258.
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Guegan, Thomas 1983. "Common neuroplasticity mechanisms underlying drugs and food reward". Doctoral thesis, Universitat Pompeu Fabra, 2013. http://hdl.handle.net/10803/125444.
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Drug addiction and some eating disorders present striking similarities in their behavioural symptoms. It has been postulated that excessive consumption of drugs of abuse and palatable food could lead to the development of similar neuronal alterations in the brainreward circuit that may account for the resemblance of these pathologies. In the present thesis, we demonstrate that repeated operant training with palatable food promotes behavioural alterations and structural plasticity changes in the esocorticolimbic circuit that are reminiscent to those observed with drugs of abuse. Furthermore, we identify the cannabinoid receptor 1 as a common neurobiological substrate underlying these alterations. Finally, we uncover several synaptic proteins commonly implicated in the retrieval of drug and palatable food rewarding memories that may represent part of the common neurobiological basis underlying drug and palatable food craving.La adicción a las drogas de abuso y determinados trastornos alimentarios comparten varios síntomas comportamentales. Algunos estudios han sugerido que el consumo excesivo de drogas y de comida palatable podrían producir alteraciones neuronales similares en el circuito cerebral de recompensa. En esta tesis, hemos demostrado que un aprendizaje operante prolongado con comida palatable provoca la aparición de alteraciones comportamentales y cambios de plasticidad estructurales en el circuito mesocorticolimbico que son reminiscentes de los observados con las drogas de abuso. Así mismo, hemos identificamos al receptor cannabinoide 1 como un sustrato neurobiológico común a estas alteraciones. Finalmente, hemos caracterizado varias proteínas sinápticas implicadas en la reactivación de la memoria asociada a los efectos placenteros de las drogas y la comida palatable. Nuestras observaciones contribuyen a definir las bases neuronales subyacentes a la necesidad de consumir drogas y comida palatable.
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Weise-Kelly, Lorraine Ann. "Drug-induced ataxia : effect of the self-administration contingency /". Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1999. http://www.collectionscanada.ca/obj/s4/f2/dsk1/tape10/PQDD_0030/NQ66245.pdf.
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Cai, Bing. "Ceramic Materials for Administration of Potent Drugs". Doctoral thesis, Uppsala universitet, Tillämpad materialvetenskap, 2015. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-245031.
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This thesis aimed to investigate and document the potential of applying ceramics in two specific drug delivery applications: tamper-resistant opioid formulations and transdermal enhancement protrusions. Geopolymers were developed into the matrix for a tamper-resistant formulation, aiming to protect drug substances from non-medical abuse. The synthesis conditions and excipients composition of the geopolymer-based formulation were modified in this work to facilitate a stable and extended drug delivery. Results showed that 37ºC 100% humidity for 48 hours were applicable conditions to obtain geopolymer with suitable mechanical strength and porosity. Moreover, it was found that the integration of poly(methyl acrylate) into the geopolymer-based formulation could reduce the drug release at low pH and, meanwhile, maintain the mechanical strength. Therefore, the geopolymer-based drug formulations concluded from these studies were applied in oral and transdermal delivery systems. Evidence of the tamper-resistance of geopolymer-based oral and transdermal formulations was documented and compared to the corresponding commercial opioid formulations. The results provided experimental support for the positive effects of geopolymers as drug carriers for the tamper-resistance of oral and transdermal delivery systems. Self-setting bioceramics, calcium phosphate and calcium sulfate were fabricated into transdermal enhancement protrusions in this work for the first time. Results showed that, under mild conditions, both bioceramics could form pyramid-shaped needles in the micron size. The drug release from these needles could be controlled by the bulk surface area, porosity and degradation of the bioceramics. An in vitro insertion test showed that the bioceramic microneedles had enough mechanical strength to insert into skin. Further optimization on the geometry of needles and the substrate material was also performed. The higher aspect-ratio needles with a flexible and self-swellable substrate could release most of the drug content within 4 hours and could penetrate through the stratum corneum by manual insertion. This study explored the potential application of bioceramics in transdermal enhancement protrusions and showed promising indication of their future developments.
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Copping, N. M. "Studies on the rectal administration of drugs". Thesis, University of Nottingham, 1985. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.372664.
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Lin, Molly. "Clinical Trial and Error: An Assessment of the Food and Drug Administration's Implementation of Breakthrough Therapy Designation". Scholarship @ Claremont, 2016. http://scholarship.claremont.edu/scripps_theses/823.
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This thesis explores the effectiveness of the Food and Drug Administration’s implementation of Breakthrough Therapy Designation (BTD), focusing on the low number of approval rates and repercussions of BTD for the development of new drugs for patients suffering serious life threatening illnesses. BTD, as an expedited review process, shows potential for improvement in its guidelines for necessary qualifications for BTD. Cutting costs, through a shortening in development time, and raising profits, through first mover status of new to market drugs, BTD is regarded by pharmaceutical executives as a tool to insure not only return on investment but also the rewards that accompanies a profitable blockbuster drug. Lessons learned from activism from 1980’s HIV/AIDS crisis show how advocates and “activist-experts” can rebalance and refocus more attention on the necessary beneficence for patients. A policy stipulation that insures all members: corporate, regulatory, and patient advocate, sit together at the decision making table will insure a more balanced discussion in regards to drug development.
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Curnutte, M. "Consuming Genomes: The Coproduction of a New Scientific and Technological Order for Genetic Testing". Doctoral thesis, Università degli Studi di Milano, 2012. http://hdl.handle.net/2434/200179.
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At the intersection of consumer culture, venture capital, biotechnology, and increased patient autonomy, a new biomedical service industry has emerged. Since 2006 companies in the US have been altering the landscape of health care by offering Direct-to-Consumer (DTC) genetic testing for a variety of diseases and traits. Recently, the activities of 23andMe and Navigenics, the two leading providers of DTC genetic services, have come under the scrutiny of various regulators and institutions, including the Food and Drug Administration (FDA) and the House of Representatives’ Committee on Energy and Commerce. In this dissertation, I situate direct-to-consumer genetic testing within the historical trajectory of genetic testing technology and the increasing profitability of information technology and biomedicine. I then analyze the recent encounters between DTC providers and regulators to identify the key scientific and discursive resources that are being employed to position the genetic testing technology with respect to regulatory initiatives. My empirical analysis of a rich set of primary sources (including websites, policy documents, and interviews) shows that the emergence of DTC genetic testing is a conspicuous instance of coproduction: a new social and technological order for genetic testing has led to the emergence of a new figure, the genetic consumer.
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Espefält, Westin Ulrika. "Olfactory Transfer of Analgesic Drugs After Nasal Administration". Doctoral thesis, Uppsala universitet, Institutionen för farmaci, 2007. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-7829.
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Nasal administration of analgesics for achieving rapid pain relief is currently a topic of great interest. The blood-brain barrier (BBB) restricts access to the central nervous system (CNS) for several central-acting drugs, such as morphine and dihydroergotamine, which results in a substantial effect delay. Evidence for the olfactory transfer of drugs from the nasal cavity to the CNS after nasal administration, bypassing the BBB, is available for both animals and humans. The aims of this thesis were to study the olfactory transfer of morphine to the CNS after nasal administration, and to compare the nasal transport of analgesic drugs across nasal respiratory and olfactory mucosa. In vivo studies in rodents demonstrated that morphine is transferred via olfactory pathways to the olfactory bulbs and the longitudinal fissure of the brain after nasal administration. Further, olfactory transfer of morphine significantly contributed to the early high morphine brain hemisphere concentrations seen after nasal administration to rats. Olfactory transfer was tracked by collecting and analysing brain tissue and blood samples after right-sided nasal administration and comparing the results to the situation after i.v. administration. The olfactory transfer was also visualised by brain autoradiography. In vitro studies indicated that the olfactory mucosa should not be a major barrier to the olfactory transfer of dihydroergotamine or morphine, since transport of these drugs was no more restricted across the olfactory mucosa than across the nasal respiratory mucosa. The in vitro studies were performed using the horizontal Ussing chamber method. This method was further developed to enable comparison of drug transport across nasal respiratory and olfactory mucosa which cannot be achieved in vivo. In conclusion, these analgesic drugs showed potential for olfactory transfer, and access to the CNS by this route should be further investigated in humans, especially for the drugs with central effects that are currently under development for nasal administration.
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Espefält, Westin Ulrika. "Olfactory transfer of analgesic drugs after nasal administration /". Uppsala : Acta Universitatis Upsaliensis Acta Universitatis Upsaliensis, 2007. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-7829.
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Falcone, Pin Bruno Nicolás. "Physicochemical properties of inhalation drugs". Thesis, University of Cambridge, 2013. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.648175.
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Tuminello, III Joseph Anthony. "The Food-Drug Relationship in Health and Medicine". Thesis, University of North Texas, 2019. https://digital.library.unt.edu/ark:/67531/metadc1505266/.
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In this dissertation, I apply Gadamerian philosophical hermeneutics to examine interpretations of the food-drug relationship within the contexts of health and medicine. Assumptions regarding the relationship between these categories undergird a substantial academic discourse and function as key components in worldviews beyond the academy. Despite this, little work has been done in foregrounding them to allow for critique and consideration of alternative perspectives. Unearthing philosophical assumptions within various fields, epistemic systems, and regulatory bodies, I classify food-drug interpretations into two main categories: dichotomous interpretations of the categories of "food" and "drugs" as ontologically distinct, and continuum-based interpretations where these categories overlap. Rather than arguing for a single appropriate way of understanding the food-drug relationship, my project aims to disclose the complexities of both sets of interpretations, illustrating their virtues and vices, and underscoring the need for people to call their own interpretations into question while taking seriously those of others. The dialogical structure of philosophical hermeneutics provides a useful foundation for dialogue within and between dichotomous and continuum-based interpretations. We do not have unmediated access to a mind-independent reality, the terms "food" and "drugs" do not necessarily refer to natural kinds, and all interpretations likely have different degrees of strengths and blind spots. Food-drug interpretations are bound up with larger worldviews, holistic systems that generate meaning for their adherents. Granting this, conversation partners can seek to gain a clearer picture of differing interpretations, what they can learn from these interpretations, and how they can interrogate their own interpretive modes.
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Brian, Janet Margaret. "The local implementation of the Sale of Food and Drugs Act, 1875". Thesis, Open University, 2006. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.429547.
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Lukashevych, I. V. "Efficacy of some herbal drugs administration for patients with urolithiasis". Thesis, БДМУ, 2017. http://dspace.bsmu.edu.ua:8080/xmlui/handle/123456789/17098.
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Popova, M. "The risk of avitaminosis due to administration of antivitamin drugs". Thesis, Київський національний університет технологій та дизайну, 2019. https://er.knutd.edu.ua/handle/123456789/14395.
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Mauludin, Rachmat [Verfasser]. "Nanosuspensions of poorly soluble drugs for oral administration / Rachmat Mauludin". Berlin : Freie Universität Berlin, 2009. http://d-nb.info/102346568X/34.
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Sorensen, Lene. "Implementation of medication reviews and use of dose administration aids for patients at risk of medication misadventure /". St. Lucia, Qld, 2002. http://www.library.uq.edu.au/pdfserve.php?image=thesisabs/absthe16806.pdf.
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Sullivan, Donald L. "Direct-to-consumer advertising of prescription drugs : measures of effectiveness /". Connect to resource, 1996. http://rave.ohiolink.edu/etdc/view?acc%5Fnum=osu1242751906.
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Davis, Jack D. "Medicine, muckraking, and the Pure Food and Drug Act of 1906 /". View online, 1988. http://repository.eiu.edu/theses/docs/32211998880620.pdf.
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Bajpai, Sanjay Kumar. "Formulary decision making in health maintenance organizations involving non-steroidal anti-inflammatory drugs /". The Ohio State University, 1992. http://rave.ohiolink.edu/etdc/view?acc_num=osu1487777901657504.
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Munday, Dale Leslie. "Design, development and evaluation of encapsulated oral controlled release theophylline mini-tablets". Thesis, Rhodes University, 1991. http://hdl.handle.net/10962/d1003255.
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Conventional solid dosage forms often lead to fluctuations which exceed the maximum safe therapeutic level and/or decline below the minimum effective level. It is recognised that many drugs for chronic administration should be administered on a schedule that maintains plasma drug concentration within the therapeutic window. Research in controlled release dosage forms aims at designing a system with a zero-order input (eg, ideally to deliver 8.33% of the dose per hour over a 12 hour duration), producing steady state plasma drug levels. Oral dministration of drugs prepared as a controlled release formulation is extremely popular, and has attracted the attention of pharmaceutical scientists during the last decade. This has been due to the simultaneous convergence of various factors (eg, discovery of novel polymers and devices, better understanding of formulation and physiological constraints, expiration of existing patents, prohibitive cost of developing new drug entities), involved in the development of these delivery systems. Controlled release oral products can be formulated as single or multiple unit dosage forms and the relative merits of multiple unit forms with their own rate controlling systems are well established. This work describes the development of a relatively inexpensive multiple-unit capsule dosage form of theophylline containing coated mini-tablets for drug delivery throughout the gastrointestinal tract. Preformulation studies on theophylline anhydrous included solubility and dissolution rate determinations. Techniques including X-ray powder diffraction, differential scanning colorimetry and infrared spectroscopy provided no evidence of true polymorphism after recrystallisation from various solvents. However, scanning electron micrographs showed the effects of solvent polarity and cooling rate on the size and shape of recrystallised particles. Theophylline granules were manufactured by using various binders and were film coated by fluidised bed technology with various proportions of ethylcellulose, containing varying amounts of PEG 1540. In vitro release rates were dependent upon coating thickness and the proportion of PEG, which, being water soluble, created pores in the coating during dissolution studies as observed by a scanning electron microscope. However, substantial proportions of the drug remained unreleased from the granules. In order to overcome the problems of drug retention, plain granules were used and theophylline mini-tablets (3 mm diameter, weighing 15 - 20 mg) were manufactured and film coated with various Eudragits ® and other polymeric mixtures (soluble and insoluble). In vitro dissolution profiles from samples enclosed in hard gelatin capsules were determined using the USPXXI paddle apparatus in test media at pH 1.2 (HCI), pH 5.4 and 7.4 (phosphate buffers) at 37'C. Monitoring of in vitro theophylline release over 12 h, under identical hydrodynamic conditions, showed that the dissolution rate at pH 1.2 is substantially greater (95% of total drug content released in < 10 h) than that in phosphate buffers. The maximum release after 12 h was approximately 20 and 30% of total drug content of the tablet at pH 5.4 and 7.4, respectively. However, in vivo bioavailability after oral administration of tablets to rabbits corresponded to over 95% of total drug, compared with the same dose administered intravenously. The retarded drug release during in vitro dissolution in phosphate buffer was attributed to a possible interaction of phosphate ions with theophylline molecules at the tablet core-coat interface. These findings indicate that both rate and extent of theophylline release from the slow release coated mini-tablets are highly sensitive to phosphate buffers. The data also emphasise the usefulness of an animal model for assessment of in vivo drug release and subsequent absorption during the development of modified release dosage forms. Mini-tablets were subjected to isothermal and cyclic stresses to reach conditions for up to 6 months at different temperatures and relative humidity. The film integrity was maintained but ageing of the coating occurred which impeded dissolution. Reduced drug release was temperature related while the effect of relative humidi% was insignific~t. Encapsulated mini-tablets (uncoated and coated with Eudragit RL and RS 2% w/w) equivalent to a 300 mg dose, were evaluated both in vitro and in vivo using beagle dogs. The pharmacokinetic parameters from single and multiple dose studies showed several advantages over Theo-Dur® 300 mg tablets. Precise dosage titration is possible by careful adjustment of the number of encapsulated mini-tablets. This multiple unit mini-tablet delivery system will allow for greater flexibility in dosage adjustment compared to the currently available preparations, allowing individualised fine dose titration in those patients requiring therapeutic drug monitoring. The developmentof the multiple unit mini-tablet formulation appears to provide an optimal dosage form with maximum flexibility in respect of dose, duration range and ease of production.
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UBOLDI, MARCO. "NOVEL SMART DEVICES FOR THE ADMINISTRATION OF DRUGS INTO HOLLOW MUSCULAR ORGANS". Doctoral thesis, Università degli Studi di Milano, 2021. http://hdl.handle.net/2434/874603.
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In questa tesi di dottorato è stato indagato il potenziale di applicazione di smart materials ed in particolare dei cosiddetti polimeri a memoria (SMPs) in campo farmaceutico. Questi ultimi, grazie alla loro capacità di rispondere a stimoli esterni modificando la propria geometria nel tempo, si configurano ad oggi come una delle tematiche di ricerca più all’avanguardia. A partire da questi materiali sono stati sviluppati sistemi di rilascio (drug delivery systems, DDSs) dalle prestazioni innovative e potenzialmente in grado di superare i limiti degli approcci terapeutici attualmente disponibili (e.g. scarsa aderenza alla terapia da parte del paziente, capacità di garantire livelli di attivo efficaci nella zona di interessa per un periodo di tempo prolungato, possibilità di personalizzazione dei sistemi). Date queste premesse, la letteratura scientifica a disposizione è stata oggetto di una valutazione approfondita, con la stesura di una review, nella quale sono stati recensititi tutti i sistemi di rilascio proposti in letteratura e realizzati a partire da SMPs, evidenziando l'obiettivo per cui i cambiamenti di forma sono stati perseguiti.
Da un punto di vista sperimentale, SMPs di grado farmaceutico sono stati impiegati per la prima volta nella realizzazione di DDSs destinati alla ritenzione, per lunghi periodi di tempo, in organi cavi di tipo muscolare, quali vescica e stomaco. A questo proposito, il processo di cambiamento di forma consentirebbe non solo la somministrazione sicura dei sistemi ma anche la relativa permanenza nel sito di interesse. Prototipi di DDSs organo-ritentivi sono stati quindi ottenuti utilizzando tecniche piuttosto innovative per la produzione farmaceutica, ovvero estrusione a caldo e stampa 3D per fused deposition modeling. È da sottolineare come, l’utilizzo di SMPs come materiali di partenza per la stampa 3D, si traduca nel nuovo concetto di stampa 4D.
Successivamente la possibilità di rivestire i campioni precedentemente realizzati e caratterizzati da una geometria particolarmente complessa si è dimostrata una strategia efficace per prolungarne la durata di rilascio senza influenzarne il comportamento di memoria di forma. Infine, i dati sperimentali raccolti sono stati accoppiati ad un modello di simulazione opportunamente validato così da accelerare le fasi di ricerca e sviluppo relative ai DDSs oggetto di studio e migliorarne le prestazioni complessive. Sfruttando questo approccio combinato sarebbe infatti possibile prevedere il comportamento a memoria di forma di prototipi complessi, riducendo al contempo il numero di oggetti fisici da preparare e testare.In this PhD thesis, the potential of smart materials, and particularly of shape memory polymers (SMPs), in pharmaceutics has been widely investigated. SMPs, with their ability to dynamically respond to specific external stimuli by changing their shape over time, currently represent one of the topics at the forefront of research. Within the pharmaceutical field their use was demonstrated able to provide innovative performance and to overcome limitations associated with the already available therapeutic approaches, e.g. poor patient compliance, ability to ensure effective drug levels at the target area for a prolonged period of time, fine tuning and customization of the overall performance. This was the main topic of a comprehensive overview of the scientific literature available, focused on SMP-based drug delivery systems (DDSs) and aimed at highlighting the objective for which the shape changes were pursued. From an experimental point of view, the possibility of using SMPs of pharmaceutical-grade in the development of DDSs intended for long-lasting retention into hollow-muscular organ, such as bladder and stomach, was approached for the first time. In this respect, the shape shifting process would ensure safe administration and enable prolonged retention at the site of interest. Feasibility of prototypes was investigated using quite novel techniques for pharmaceutical manufacturing, i.e. hot melt extrusion and fused deposition modeling 3D printing, the latter providing the tool for 4D printing when dealing with SMPs as starting materials. Film-coating of SMPs-based prototypes having complex geometries was also demonstrated as a viable strategy to prolong the release duration without affecting the shape memory behavior. Moreover, the comprehensive experimental campaign carried out was coupled with computer-aided simulation modelling to accelerate the R&D stages and to improve the overall performance of the DDSs proposed. In fact, thanks to this approach, it would be possible to predict the shape memory behavior of complex prototypes while reducing the number of physical samples to be attained.
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Honda, Kazuhisa, Hiroshi Kamisoyama, Noboru Saito, Yohei Kurose, Kunio Sugahara i Shin Hasegawa. "Central administration of glucagon suppresses food intake in chicks". Elsevier, 2007. http://hdl.handle.net/2237/9266.
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Marasanapalle, Venugopal P. "Factors contributing to and predictive models for drugs exhibiting negative food effects of unknown mechanisms". Scholarly Commons, 2007. https://scholarlycommons.pacific.edu/uop_etds/2356.
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Drugs exhibiting decreased extent of absorption in the fed state administration when compared to the fasted state administration are termed to exhibit a negative food effect. The known causes for negative food effects are luminal degradation and complexation to metal ions/Ca 2+ . For the drugs that do not undergo GI degradation and metal ion complexation, different factors were attributed to cause negative food effects, which are inconclusive. The objectives of this investigation were; to identify the physicochemical and physiological changes between fasted and fed states and their role in causing negative food effects; to develop an empirical model that correlates the biopharmaceutical properties of molecules to negative food effects; and translate the empirical model to a mechanistic model and explain the mechanisms of negative food effects for drugs that do not have clearly defined mechanisms of negative food effects. The important physicochemical change in the upper intestine was identified to be pH. The pH of the upper intestine in the fasted state is typically 6.5, whereas, the overall post-prandial pH after a standard meal in the duodenum is 5.4 (5.0 − 5.7) and the jejunal pH is 4.7 owing to the emptying of acidic chyme. Negative food effect drugs exhibited incomplete GI absorption, low Log P values and low apical to basolateral Caco-2 permeabilities. Acidic/basic drugs exhibiting either negative food effects or no food effects with a molecular size range of 200–450 Da and no physiological effects (such as secretions and motility) were selected from the literature. Multiple linear regression analysis using five drugs exhibiting negative food effects and seven drugs exhibiting no food effects indicated that, percent food effects correlated to acidic/basic dissociation constants (Ka/Kb) and to Caco-2 permeability (R 2 = 0.9114, Power ≈ 1 and p < 0.00002). A mathematical model, adopted to understand the mechanisms of negative food effects suggested that, lowering of permeability or solubility of the model compounds at the lower pH of the postprandial upper intestinal state may contribute to their negative food effects. Finally, this model was found to be useful in predicting negative food effects using in situ rat permeability values.
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Patel, Fathima. "The development and assessment of a generic carbamazepine sustained release dosage form". Thesis, Rhodes University, 2006. http://eprints.ru.ac.za/1339/.
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Hansen, Tue. "Spray-dried o/w-emulsions for oral delivery of poorly soluble drugs /". Cph. : The Danish University of Pharmaceutical Sciences, Department of Pharmaceutics, 2004. http://www.dfh.dk/phd/defences/tuehansen.htm.
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Heard, Sharon D. "Evaluation of Bureau Practice for Illegal Drugs Use Among Teens". ScholarWorks, 2011. https://scholarworks.waldenu.edu/dissertations/1126.
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The Bureau of Substance Abuse Treatment Recovery and Prevention, which oversees drug intervention services for Detroit residents, has found the city's illegal drug use among teens to mirror national rates. Illegal drug use is associated with addiction, major health problems, and stigma. Incorporating evidence-based screening during all teen health care visits would decrease missed opportunities to identify at-risk behaviors, the number of teens that do not receive intervention, and the stigma associated with screening. The purpose of this project was to develop evidence-based policy and practice guidelines for teen screening services for illegal drug use. The Plan-Do-Study-Act (PDSA) model was used to guide the project. An interdisciplinary team of direct service and administrative staff selected questions based on 6 key words---car, relax, alone, forget, friends, and trouble (CRAFFT)---to screen teens for illegal drug use. The interdisciplinary team also developed a teen screening policy along with practice guidelines for the screening policy, implementation plan, and project evaluation. A review of the literature provided support for the project methods. Two experts in the field of substance abuse provided content validity for the policy and practice guidelines, and concluded that the CRAFFT screening questions were valid for evidence-based screening for illegal drug use among teens, that the PDSA model was effective to guide the project, and that an interdisciplinary team approach was effective to address the issue. These findings may improve identification of at-risk teens, decrease missed screening opportunities, decrease stigma, and align the Bureau with current trends in substance abuse treatment.
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Cabrera, Brooke A. "The impact of direct-to-consumer (DTC) prescription drug advertising on the pharmaceutical salesperson/doctor relationship : a pilot study". Honors in the Major Thesis, University of Central Florida, 2003. http://digital.library.ucf.edu/cdm/ref/collection/ETH/id/310.
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This item is only available in print in the UCF Libraries. If this is your Honors Thesis, you can help us make it available online for use by researchers around the world by following the instructions on the distribution consent form at http://library.ucf.edu/Systems/DigitalInitiatives/DigitalCollections/InternetDistributionConsentAgreementForm.pdf You may also contact the project coordinator, Kerri Bottorff, at kerri.bottorff@ucf.edu for more information.Bachelors
Business Administration
Marketing
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Gersper, Beth E. "NETWORK ANALYSIS OF DRUGS OF ABUSE IN OHIO AND POLICY IMPLICATIONS". University of Akron / OhioLINK, 2019. http://rave.ohiolink.edu/etdc/view?acc_num=akron156761393419992.
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Albiol, Chiva Jaume. "Analysis of Antitumoral and Antibiotic Drugs in Biological Fluids, Food and Pharmaceuticals through Micellar Liquid Chromatography". Doctoral thesis, Universitat Jaume I, 2020. http://hdl.handle.net/10803/668887.
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The thesis exposes and develops the analysis by Micellar Liquid Chromatography (MLC) of different methods for the determination of compounds of medical and pharmaceutical interest, in biological fluids (plasma and urine), pharmaceutical compounds and food. The compounds analyzed are: antitumor group Tyrosine Kinase Inhibitors (TKIs: Afatinib, Axitinib, Dabrafenib, Lapatinib, Pazopanib, Regorafenib), Antituberculous (Rifampicin, Rifabutin, Isoniazide, B6), Oral Anticoagulant (Rivaroxaban), Antibiotic group Fluoroquinolone (Flumequine, Marbofloxacin, Difloxacin, Sarafloxacin, Oxolinic acid, Ciprofloxacin, Enrofloxacin, Sarafloxacin). All procedures have been validated following guidelines for validation of analytical methods established by official institutions (EMA, FDA, ICH, EC) depending on the type of sample and matrix analyzed for each compound, in order to guarantee the reliability and quality of the results . One of the advantages of MLC is that it allows the direct injection of physiological and food samples, which considerably reduces the stage of pretreatment of the same, as well as the loss of analytes. Another advantage is that the micellar mobile phases use a smaller amount of organic solvent than those used in conventional HPLC, which reduces the costs of analysis and favors the achievement of objectives set by the European Union in relation to the "Green Chemistry" . In any case, all the analysis methods included in this thesis show their validity and application for the control of the compounds in real samples analyzed.La tesis expone y desarrolla el análisis mediante cromatografía Líquida Micelar (MLC) de diferentes métodos para la determinación de compuestos de interés médico y farmacéutico, en fluidos biológicos (plasma y orina), compuestos farmacéuticos y alimentos. Los compuestos analizados són: grupo antitumoral Inhibidores de Tirosin Kinasa (TKIs: Afatinib, Axitinib, Dabrafenib, Lapatinib, Pazopanib, Regorafenib), Antituberculosos (Rifampicina, Rifabutina, Isoniazida, B6), Anticoagulante Oral (Rivaroxaban), Antibióticos del grupo de las Fluoroquinolonas (Flumequine, Marbofloxacin, Difloxacin, Sarafloxacin, Oxolinic acid, Ciprofloxacin, Enrofloxacin, Sarafloxacin). Todos los procedimientos han sido validados siguiendo guías de validación de procesos analíticos establecidas por organismos oficiales (EMA, FDA, ICH, EC) dependiendo del tipo de muestra y matriz analizada para cada compuesto, con el objetivo de garantizar la fiabilidad y calidad de los resultados. Una de las ventajas del MLC es que permite la inyección directa de muestras fisiológicas y de alimentos, lo que reduce considerablemente la etapa de pretratamiento de las mismas, así como la pérdida de analitos. Otra ventaja es que las fases móviles micelares utilizan una menor cantidad de disolvente orgánico que las empleadas en la HPLC convencional, lo que reduce los costes de analísis y favorece la consecución de objetivos marcados por la Unión Europea en lo referente a la "Green Chemistry". En todo caso, todos los métodos de análisis incluidos en esta tesis muestran su validez y aplicacíón para el control de los compuestos en muestras reales analizadas.
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Lee, Hwang-Jaw. "Nonparametric and parametric analyses of food demand in the United States /". The Ohio State University, 1991. http://rave.ohiolink.edu/etdc/view?acc_num=osu1487685204967625.
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Komperlla, Mahesh Kumar. "The formulation and evaluation of rapid release tablets manufactured from Artemisia Afra plant material". Thesis, University of the Western Cape, 2004. http://etd.uwc.ac.za/index.php?module=etd&.
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Infusions, decoctions, alcoholic preparations and other dosage forms of Artemisia afra are frequently used in South African traditional medicine. Generally when these preparations are made without applying good manufacturing practices they do not meet microbial quality control standards, safety and toxicity criteria and encourage poor patients compliance. To overcome the aforementioned disadvantages of traditional dosage forms a sold dosage form, i.e. a table might be recommended. The first objective of this study was to formulate and manufacture a rapid release tablet dosage of Artemisia afra that would contain an amount of plant material equivalent to that found in its traditional liquid dosage forms and that would meet conventional pharmaceutical standards. The second objective was to conduct a pilot study to obtain a preliminary profile of the bioavailability of select flavonoids presents in both the tablet and traditional liquid preparation of Artemisia afra in humans.
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Hu, Leijun. "Suramin pharmacokinetics after regional or systemic administration". Connect to resource, 2005. http://rave.ohiolink.edu/etdc/view?acc%5Fnum=osu1114449390.
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Wu, Jiawei, i Fenghu Chen. "Knowing more about people ordering food online: based on Eleme platform". Thesis, Internationella Handelshögskolan, Högskolan i Jönköping, IHH, Företagsekonomi, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:hj:diva-38205.
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LIN, SHIHKUO. "STUDY OF ENVIRONMENTAL CONTAMINANTS AND VETERINARY DRUGS, RESIDUES THROUGHOUT THE FOOD CHAIN RELATED TO SWINE AND POULTRY, AND EVENTUALLY OTHER SPECIES OF FOOD-PRODUCING ANIMALS". Doctoral thesis, Università degli Studi di Milano, 2020. http://hdl.handle.net/2434/704040.
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La carne e i prodotti a base di carne sono le principali fonti di diete umane. La salute degli animali da produzione alimentare dovrebbe essere adeguatamente monitorata e controllata al fine di ridurre i rischi per la catena alimentare. Gli studi presentati in questa tesi includevano le strategie di (i) valutare l'esito della spedizione del rapporto patologico agli allevamenti di suini di provenienza e (ii) sviluppare il metodo di rilevazione e studiare la prevalenza di contaminanti ambientali e farmaci veterinari nel maiale, vitello, uova di gallina e alimenti per bambini. Nel capitolo 3, abbiamo raccolto i record delle ispezioni delle carni a livello nazionale. Il numero di grandi allevamenti rappresenta il 9% del totale ma hanno prodotto il 48,5% di suini da macello. Per la percentuale di lesioni patologiche nelle carcasse, i suoi coefficienti di variazione (CV) sono del 42% nella classe dei grandi allevamenti. Ciò suggerisce che il livello di salute nei grandi allevamenti era più omogeneo rispetto agli quelli piccoli e medi. Al termine dello studio, abbiamo analizzato le influenze delle lesioni patologiche dopo aver inviato il risultato post mortem agli allevamenti di provenienza. I risultati evidenziano che le percentuali di fegato e polmone sono gradualmente ridotte dello 0,02% al mese. Il feedback sui risultati post mortem migliora la trasparenza delle informazioni governative, la collaborazione tra produttori e veterinario ufficiale e la salute della mandria per alimenti più sicuri di origine animale. Nei capitoli 4, 5 e 6, abbiamo sviluppato I metodi di rilevazione altamente sensibili su sostanze perfluoroalchiliche (PFAS), bifenili policlorurati (PCB), idrocarburi policiclici aromatici (IPA), eteri difenilici polibromurati (PBDE), pesticidi e antibiotici. Il limite di quantificazione (LOQ) è 0,015-0,15 ng g-1 in PFAS, 0,5 ng g-1 in PBDE, il che è conforme alla decisione 2002/657/CE della Commissione. Abbiamo applicato i nostri metodi per lo studio di diverse matrici animali: maiale, vitello e alimenti per bambini. I risultati suggeriscono che la prevalenza di contaminanti ambientali in carne di maiale, vitello e alimenti per bambini sono bassi e non comportano rischi per la salute umana. Nel capitolo 7, abbiamo sviluppato un metodo rapido e facile da applicare per rilevare il fipronil e il suo metabolita e l'amitraz dalle uova di gallina. Il LOQ è 0,89 ng g-1 in fipronil e 2,4 ng g-1 in amitraz. I risultati descritti in questa tesi consistono nella chiara comprensione dei metodi di rilevazione di contaminanti ambientali e farmaci veterinari nei suini, vitelli e pollami. Inoltre, tramite la mail di feedback, i produttori di suini hanno ricevuto le osservazioni continue dal macello, quindi hanno intrapreso azioni per ridurre le lesioni patologiche. I risultati introdotti in questa tesi possono essere il modo futuro di mantenere la sicurezza lungo tutta la catena alimentare.Meat and meat products are the principal sources of human diets. The health of food-producing animals should under proper monitoring and control in order to reduce risks to the food supply chain. The studies presented in this thesis included the strategies of (i) Evaluate the outcome of feeding back the pathological report to the origin pig farms, and (ii) Build up the detection method and investigate the prevalence for environmental contaminants and veterinary drugs in pork, veal, chicken eggs and baby foods. In Chapter 3, we collected meat inspection records at a national level. The number of large farms account for 9% of the total but produced 48.5% slaughtering pigs. About the percentage of pathological lesions in the carcass, its coefficients of variation (CVs) is of 42% in the class of large farms. It suggests that the health level in large farms were more homogenous than in small and medium ones. At the final of the study, we analysed the influences of pathological lesions after having sent the post-mortem result to pig producers. The results highlight that the percentages of liver and lung had gradually reduced by 0.02% per month. The feedback of post-mortem result improves the transparency of government information, the close collaboration between producers and official veterinarian, and the herd health, for safer food of animal origin. In Chapter 4, 5 and 6, we developed highly sensitive detection methods on perfluoroalkyl substances (PFASs), polychlorinated biphenyls (PCBs), polycyclic aromatic hydrocarbons (PAHs), polybrominated diphenyl ethers (PBDEs), pesticides, and antibiotics. The limit of quantification (LOQ) is 0.015-0.15 ng g-1 in PFASs, 0.5 ng g-1 in PBDE, which complied with Commission Decision 2002/657/EC. We applied our methods for the investigation of several animal matrices: pork, veal, and baby food. The results suggest that the prevalence of environmental contaminants in pork, veal, and baby food are low and do not post risks to human health. In Chapter 7, we developed a quick and easy-to-apply method to detect Fipronil and its metabolite and Amitraz from chicken eggs. The LOQ is 0.89 ng g-1 in Fipronil, and 2.4 ng g-1 in Amitraz. The outputs described in this thesis consists of clear understanding of detection methods for environmental contaminants and veterinary drugs in swine, calves and poultry. Besides, via the feedback mail, the pig producers received continuous observations from the slaughterhouse. Thus they took actions to reduce pathological lesions. The results introduced in this thesis can be the future way to keep food safety throughout the food chain.
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Rosito, Amanda, i Ezzat Kassem. "More than just a food! : A qualitative study on functional food from the Swedish Millennials' perspective". Thesis, Högskolan i Jönköping, Internationella Handelshögskolan, 2019. http://urn.kb.se/resolve?urn=urn:nbn:se:hj:diva-43921.
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Background: In Sweden, consumers have become more aware that certain types of food could improve their health and overall well-being. In addition, consumers, especially Swedish Millennials, are getting healthier day after day. Accordingly, manufacturers responded to this phenomenon by supplying food that offers extra health benefits (Ring & Mitchell, 2010). These types of food are called Functional Food (FF) and are defined as “food enriched with different components (such as vitamins, minerals or probiotic cultures) or modified in a way that the product provides an additional physiological benefit that might prevent disease and promote health” (Morna, 2015:336). Purpose: The study investigates the Swedish Millennials healthy lifestyle and focuses on their attitudes towards the functional food. Thus, the authors will explore the whole lifestyle and habits of the Swedish Millennials reaching to the core of the research, which is the consumption of the functional food. Method: In order to fulfil the purpose of this study an exploratory method, with qualitative and abductive approach, is chosen to understand the Swedish Millennials attitude towards the functional food. The focus group was the tool to collect the data for the study. In total, five focus groups were conducted with twenty-six participants all of them are Swedish Millennials. The reason behind choosing focus groups tool is to comprehend deeply the Swedish Millennials lifestyle and specifically their attitude towards the functional food. Conclusion: The authors concluded that the Swedish Millennials have a systematic lifestyle and they feel comfortable with the routine. The Swedish Millennial’s attitude towards the functional food is considered positive to the majority of the participants in the research. However, the minority of the Swedish Millennial’s participants have a negative attitude towards the functional food. Therefore, it was concluded that the Swedish Millennials attitude to an extent is positive towards the functional food consumption.
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Praveen, Kumar K. "Methodologies for the analysis of veterinary drugs and growth promoters in the scope of food safety control". Doctoral thesis, Universitat de Barcelona, 2014. http://hdl.handle.net/10803/279347.
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Veterinary drugs and growth promoters are a part of many chemical hazards that can be found in the modern food chain, and they pose risks to human health such as antimicrobial resistance. The presence of these drug residues increased with intensive farming practices and is an issue of global concern. Food safety authorities around the world establish control programs by scientifically assessing the risk for each drug and set maximum levels for each drug in various matrices. The testing laboratories and analytical methods to test samples from food and feed chain form the core of such programs and provide evidence for regulatory authorities to take decisions. In the drug residue testing, there is a need for improved methods of testing that can provide high selectivity, high throughput, robustness and affordability. In that sense, one main goal of this thesis was to develop analytical methodologies for various families of veterinary drugs and growth promoters in feed, food and biological samples from food producing animals.
First three chapters form the introduction of this thesis. Chapter 1 provides an overview on food safety hazards, food safety authorities, legislations for control of veterinary drugs and growth promoters and the role of analytical laboratories in the control program. Chapter 2 covers sample preparation techniques and the typically used chromatographic (LC) and detection (MS) techniques for drug residue testing. Chapter 3 reviews various applications in literature and focus on trends in developing analytical methodologies for food safety testing which move in the direction of comprehensive analysis of samples owing to very high number of contaminants and increasing number of unknown contaminants.
Chapter 4 presents a method developed and validated for analyzing eight sulphonamides in six types of feed based on liquid chromatography (LC) and ultraviolet detection.
Chapter 5 presents the results from a systematic study of various hydrophilic interaction chromatography (HILIC) stationary phases for analysis of aminoglycosides and also reports two analytical methods based on HILIC- tandem mass spectrometry (MS/MS) for analysis of ten aminoglycosides in honey and animal kidney samples. This work was carried out in collaboration with laboratory of Agencia Salut Publica de Barcelona (ASPB) and the methods were validated according to Decision 2002/657/EC and implemented for routine analysis of samples in accordance with the requirements of ISO 17025: 2005. The laboratory of ASPB acquired an LC- high resolution mass spectrometry (HRMS) instrument and in order to incorporate the instrument for routine targeted analysis, an exploration of various parameters of the equipment was necessary. In that sense, a systematic study to explore various modes of acquisition has been conducted and a method to analyze nine hormones in urine has been transferred to HRMS and is reported in Chapter 6. Gaining understanding about the functioning of the instrument, an improved method to analyze aminoglycosides based on HRMS was developed and reported in Chapter 5.4. Moreover, the LC- HRMS instrument with quadrupole-orbitrap hybrid analyzer has been incorporated in the laboratory for resolving ambiguous test results. A case study of resolving a false positive result from the analysis of ronidazole in meat was presented in Chapter 7. This case study highlights the pitfalls with low resolution mass spectrometry and existing confirmation criteria for identification with mass spectrometric detection.
The HRMS in food safety testing for comprehensive analysis of samples, a non targeted screening workflow using various HRMS data mining and analysis tools have been developed and presented in Chapter 8.
At the end of this thesis, conclusions and outlook are presented followed by a list of bibliographic literature.Los medicamentos veterinarios y promotores del crecimiento forman parte de los muchos peligros químicos que se pueden encontrar en la cadena alimentaria moderna. Estos pueden representar un riesgo para la salud humana puesto que están relacionados con la aparición de la resistencia a los antimicrobianos. La presencia de estos residuos de medicamentos ha aumentado debido a las prácticas de agricultura intensiva y es un tema de preocupación global. Las autoridades de seguridad alimentaria establecen programas de control mediante la evaluación científica del riesgo de cada medicamento, y también establecen los niveles máximos de cada medicamento en diversas matrices. Los laboratorios de ensayo y métodos analíticos para analizar muestras de alimentos y piensos forman el núcleo de este tipo de programas y proporcionan evidencias a las autoridades reguladoras en su toma de decisiones. En el campo de análisis de residuos, existe una necesidad de mejorar los métodos de análisis para que puedan proporcionar una alta selectividad, alto rendimiento, elevada robustez y razonable asequibilidad. En ese sentido, el objetivo principal de esta tesis fue el desarrollo de metodologías analíticas para varias familias de fármacos de uso veterinario y promotores del crecimiento en piensos, alimentos y muestras biológicas de los animales que producen alimentos. Los primeros tres capítulos son la introducción de esta tesis. El Capítulo 4 presenta un método desarrollado y validado para el análisis de ocho sulfonamidas en seis tipos de piensos mediante cromatografía de líquidos (LC) y detección ultravioleta. El Capítulo 5 presenta los resultados de un estudio sistemático de diferentes fases estacionarias de cromatografía de interacción hidrófila (HILIC) para el análisis de aminoglucósidos y también reporta dos métodos analíticos basados en espectrometría de masas en tándem acoplada a HILIC para el análisis de diez aminoglucósidos en muestras de riñón de animales y miel. Un estudio sistemático para explorar distintos modos de adquisición en un instrumento de espectrometría de masas de alta resolución (HRMS, Q-Orbitrap) acoplada a cromatografía líquida y un método para analizar nueve hormonas en orina se detalla en el capítulo 6. Un método mejorado para analizar los aminoglucósidos basado en HRMS fue desarrollado y se presenta en el Capítulo 5.4. Un estudio de un caso práctico sobre la resolución de un resultado falso positivo en análisis de ronidazol en carne se presenta en el Capítulo 7. Se ha desarrollado un workflow de análisis non targeted utilizando diversas herramientas de minería de datos y de análisis, que se ha aplicado a una muestra de sedimento y presentado en el capítulo 8.