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Journal articles on the topic 'Drug development'

Author: Grafiati

Published: 4 June 2021

Last updated: 16 November 2024

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1

Mishra, Hara Prasad, Ayush Goel, Sahil Kumar, Mihir Chauhan, Mrinal Patnaik, and Imaad Rehman. "Drug development hit by war." Journal of Pharmacovigilance and Drug Research 3, no. 2 (June 1, 2022): 11–15. http://dx.doi.org/10.53411/jpadr.2022.3.2.3.

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2

Jadhav, Mr Gahininath Thansing, and Mr Rahul Bhavlal Jadhav. "Drug Discovery and Development Process." International Journal of Research Publication and Reviews 5, no. 1 (January 8, 2024): 1891–95. http://dx.doi.org/10.55248/gengpi.5.0124.0225.

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3

Adukondalu, D., Rajesh Rajesh, Shaik Thaslim, E. Soumya, and M. Chandana. "Regulatory Guidelines for New Drug Development." Pharmaceutics and Pharmacology Research 4, no. 3 (September 25, 2021): 01–11. http://dx.doi.org/10.31579/2693-7247/046.

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Aim: The aim of present project work is to understand the guidelines and regulatory requirements for investigational new drug and development of new drug Objectives: The objective of current project include Need of a new drug to investigate New drug development targets Understanding the properties of new dug Required protocols for submission of new drug to regulatory authority Regulatory requirements to get approval of new drug.

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4

Sharma, Bhavik. "DRUG DISCOVERY AND DEVELOPMENT: AN OVERVIEW." INDIAN RESEARCH JOURNAL OF PHARMACY AND SCIENCE 7, no. 2 (June 2020): 2215–26. http://dx.doi.org/10.21276/irjps.2020.7.2.14.

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5

Agrawal, Shrutidevi, Narisetty Sunil Thomas, Anand Babu Dhanikula, Chaman Lal Kaul, and Ramesh Panchagnula. "Antituberculosis drugs and new drug development." Current Opinion in Pulmonary Medicine 7, no. 3 (May 2001): 142–47. http://dx.doi.org/10.1097/00063198-200105000-00005.

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6

GRABOWSKI, H. G. "Issues of Drug Development: Orphan Drugs." Science 228, no. 4702 (May 24, 1985): 981. http://dx.doi.org/10.1126/science.228.4702.981.

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7

Vaalburg, Willem, N. Harry Hendrikse, and Erik F. J. de Vries. "Drug development, radiolabeled drugs and PET." Annals of Medicine 31, no. 6 (January 1999): 432–37. http://dx.doi.org/10.3109/07853899908998801.

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8

Flaherty, Keith T., Dung T. Le, and Steven Lemery. "Tissue-Agnostic Drug Development." American Society of Clinical Oncology Educational Book, no. 37 (May 2017): 222–30. http://dx.doi.org/10.1200/edbk_173855.

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The U.S. Food and Drug Administration (FDA) has approved drugs to treat patients with tumor types based on a single anatomic site, such as renal cell carcinoma or melanoma, rather than on a biomarker alone. This standard approach is based on a number of factors, including heterogeneity of drug effects in different biomarker-positive tumor types. Additionally, drug development for some drugs was primarily directed toward a specific genomic abnormality in a specific tumor type (e.g., drugs for anaplastic lymphoma kinase [ALK] fusion-positive non–small cell lung cancer). In such cases, differences in biology, differences in natural histories of different cancers, differences in mutation frequencies among cancers, or differences in concomitant therapies may have necessitated diverse development considerations. As described in U.S. regulations [21 CFR 201, CFR 201.57(c)(2)], the indications and usage section of drug labeling “must state that a drug is indicated for the treatment, prevention, mitigation, cure, or diagnosis of a recognized disease or condition or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.” Such regulations, however, do not require that disease be defined solely as a specific tumor type. This manuscript will highlight scientific/biologic issues, clinical trial designs, and regulatory issues pertaining to the development of drugs agnostic of tumor type. Although the manuscript will discuss regulatory considerations as understood by the authors regarding tissue-agnostic drug development, it should not be considered formal or binding FDA guidance or policy.

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9

Yamashiro, Yuichiro, Jennifer Martin, Madlen Gazarian, Sharon Kling, Hidefumi Nakamura, Akira Matsui, Salvatore Cucchiara, Marina Aloi, Erica L. Wynn, and Andrew E. Mulberg. "Drug Development." Journal of Pediatric Gastroenterology and Nutrition 55, no. 5 (November 2012): 506–10. http://dx.doi.org/10.1097/mpg.0b013e318272af1f.

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10

Williams, Ian. "Drug Development." Science 277, no. 5322 (July 4, 1997): 17.6–21. http://dx.doi.org/10.1126/science.277.5322.17-f.

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11

Williams;, I. "Drug Development." Science 277, no. 5322 (July 4, 1997): 17e—21. http://dx.doi.org/10.1126/science.277.5322.17e.

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12

BRENNAN, MAIRIN. "DRUG DEVELOPMENT." Chemical & Engineering News 74, no. 44 (October 26, 1996): 10. http://dx.doi.org/10.1021/cen-v074n044.p009.

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13

HENRY, CELIA M. "DRUG DEVELOPMENT." Chemical & Engineering News 80, no. 21 (May 27, 2002): 53–66. http://dx.doi.org/10.1021/cen-v080n021.p053.

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14

Komatsu, Kanji. "Statistical Models for Model-Based Drug Development." Japanese Journal of Biometrics 32, Special_Issue_2 (2011): 179–93. http://dx.doi.org/10.5691/jjb.32.179.

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15

K. Kapoor, Vijay, and Amanpreet Kaur. "Drug-Glycosidation and Drug Development." Mini-Reviews in Medicinal Chemistry 13, no. 4 (March 1, 2013): 584–96. http://dx.doi.org/10.2174/1389557511313040010.

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16

Garepally, Prasad, Swathi Goli, and Vijay Kumar Bontha. "Design, Development and Characterizations of Acyclovir Osmotic Tablets." Pharmaceutics and Pharmacology Research 1, no. 1 (October 8, 2018): 01–14. http://dx.doi.org/10.31579/2693-7247/005.

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Oral drug delivery is the most widely utilized route of administration, among all the routes of administration. That has been explored for the systemic delivery drug through different pharmaceutical dosage forms. It can be said that at least 90%of all drugs used to produce systemic effect is by oral route. Conventional oral drug delivery systems are known to provide an immediate release of drug, in which one cannot control the release of the drug and effective concentration at the target site.

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17

Drews, Jürgen, and Stefan Ryser. "Drug Development: The role of innovation in drug development." Nature Biotechnology 15, no. 13 (December 1997): 1318–19. http://dx.doi.org/10.1038/nbt1297-1318.

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18

DiMasi, Joseph A., and Henry G. Grabowski. "Economics of New Oncology Drug Development." Journal of Clinical Oncology 25, no. 2 (January 10, 2007): 209–16. http://dx.doi.org/10.1200/jco.2006.09.0803.

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Purpose Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. Methods We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. Results We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. Conclusion The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.

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19

Kusuhara, Hiroyuki. "Development of endogenous biomarkers to assess drug-transporter-mediated drug-drug interactions in drug development." Proceedings for Annual Meeting of The Japanese Pharmacological Society 94 (2021): 3—S32–4. http://dx.doi.org/10.1254/jpssuppl.94.0_3-s32-4.

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20

AMIN, Dipti, and Jean-Pierre ISAL. "Evaluation of Drug-Drug Interactions in Drug Development." Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics 34, no. 1 (2003): 193S—194S. http://dx.doi.org/10.3999/jscpt.34.193s.

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21

Gandhi, Karan, Umang Shah, and Sandip Patel. "Drug Stereochemistry: A Prodigy For Pharmacology and Drug Development." Current Drug Discovery Technologies 17, no. 5 (December 23, 2020): 565–73. http://dx.doi.org/10.2174/1570163816666190502101803.

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Stereochemistry has evinced the importance of many chiral drugs with respect to drug designing and development. A literature review was conducted for several chiral drugs involving pharmacokinetic and pharmacodynamic parameters of their enantiomers along with their uses in certain diseased conditions. This article mainly includes the pharmacological profile review of some chiral drugs and the aspects due to which the single enantiomer is of importance as compared to the racemic mixture of the drug. This was achieved by moderating the side effects or toxic effects; or by the potentiated activity of the single enantiomer. Resolution deals with the separation of racemic compounds which shows up the credibility to obtain the desired enantiomeric properties. As isomers vary in their pharmacokinetic and pharmacodynamic profiles, chiral drugs have showcased considerable importance in the drug development process. Both the enantiomers have a different pharmacological profile in the treatment of a disease, which differentiates them from drug racemates.

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22

GS, Lavekar. "Concept of Integrated Drugs Development." Journal of Natural & Ayurvedic Medicine 7, no. 3 (August 4, 2023): 1–4. http://dx.doi.org/10.23880/jonam-16000413.

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Drugs are an integral part of treatment in health care, it is a belief that the drugs should be free from side effects should be safe and not to create any disease. The chemical or allopathic drugs which are having some side effects may be combined with Ayurveda herbal drugs to pacify their side effects or bring to minimal level. Another aspect is that the Ayurved herbal drugs are slow and weak in action, but quite safe, on other side the allopathic drugs are comparatively fast, bit strong but with some side effects. If these two are combined like an example of anti-diabetic allopathic drug metformin which is most prescribed. The Metformin is having some side effects like diarrhoea, metallic test, loss of appetite etc., on other side ayurvedic anti-diabetic drug Andrographis paniculate may be a safe combination as Andrographis has protective effects on gastrointestinal tract also. Such integrative approaches will be an ideal in developing integrative potential and safe drugs. This strategy will work effectively and may find an innovative solution for lifestyle related diseases.

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23

Rehan Haider, Asghar Mehdi, Anjum Zehra, Geetha Kumari Das, Zameer Ahmed, and Sambreen Zameer. "Drug Development Research in Women." International Journal of Scientific Multidisciplinary Research 2, no. 5 (May 31, 2024): 415–40. http://dx.doi.org/10.55927/ijsmr.v2i5.8807.

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Drug research in wives is a critical district that has acquired growing consideration in recent ages. Historically, mothers have diminished in clinical tests, chief to a lack of understanding about in what way or manner drugs influence them otherwise distinguished to brothers. This information gap has important associations for drug security and efficiency, as physiological dissimilarities between genders can impact drug absorption, productiveness, and adverse belongings. In answer, skilled has existed a growing importance on containing girls in dispassionate trials and attending grammar principles that apply to nouns with sexual or animated connotations reasonings to guarantee that drugs are safe and persuasive for two together people interested in something. This paper provides an overview of the significance of containing mothers in drug-producing research. It discusses the classical circumstances of feminine bias in dispassionate trials and the supervisory changes that have been executed to address this issue. The paper again highlights the corporeal and hormonal distinctnesses middle from two points people that can influence drug responses. Furthermore, the paper tries to the challenges and space in drafting and maintaining women in dispassionate tests, containing righteous considerations and educational determinants

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24

Shafer, Robert W., and Jonathan M. Schapiro. "Drug resistance and antiretroviral drug development." Journal of Antimicrobial Chemotherapy 55, no. 6 (April 21, 2005): 817–20. http://dx.doi.org/10.1093/jac/dki127.

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25

GAD, S. "Active drug metabolites in drug development." Current Opinion in Pharmacology 3, no. 1 (February 2003): 98–100. http://dx.doi.org/10.1016/s1471-4892(02)00003-6.

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26

Matsubara, Takashi. "Safety Evaluation and Drug Development based on Biological Fate of Drugs —Efforts Made to Overcome Drug Interaction in Drug Development—." Drug Metabolism and Pharmacokinetics 17, no. 5 (2002): 379–94. http://dx.doi.org/10.2133/dmpk.17.379.

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27

Alderton, Gemma. "Diversifying drug development." Science 371, no. 6529 (February 4, 2021): 580.9–582. http://dx.doi.org/10.1126/science.371.6529.580-i.

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28

Field, Hugh J., and Mark A. Wainberg. "Antiviral drug development." Future Virology 6, no. 5 (May 2011): 545–47. http://dx.doi.org/10.2217/fvl.11.36.

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29

Loadman, P. "Anticancer Drug Development." British Journal of Cancer 86, no. 10 (May 2002): 1665–66. http://dx.doi.org/10.1038/sj.bjc.6600309.

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30

Vaughan Williams, E. M. "ANTIARRHYTHMIC DRUG DEVELOPMENT." American Journal of Therapeutics 2, no. 4 (April 1995): 233–36. http://dx.doi.org/10.1097/00045391-199504000-00002.

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31

Somberg, John C. "Pediatric Drug Development." American Journal of Therapeutics 10, no. 1 (January 2003): 2. http://dx.doi.org/10.1097/00045391-200301000-00002.

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32

Donnan, Geoffrey A., and Stephen M. Davis. "Stroke Drug Development." Stroke 36, no. 10 (October 2005): 2326. http://dx.doi.org/10.1161/01.str.0000179042.06535.2f.

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33

Luetkemeyer, Anne F., Haileyesus Getahun, Gabriel Chamie, Christian Lienhardt, and Diane V. Havlir. "Tuberculosis Drug Development." American Journal of Respiratory and Critical Care Medicine 184, no. 10 (November 15, 2011): 1107–13. http://dx.doi.org/10.1164/rccm.201106-0995pp.

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34

Ades, Felipe, Dimitrios Zardavas, Philippe Aftimos, and Ahmad Awada. "Anticancer drug development." Current Opinion in Oncology 26, no. 3 (May 2014): 334–39. http://dx.doi.org/10.1097/cco.0000000000000076.

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35

Preskorn, Sheldon H. "CNS Drug Development." Journal of Psychiatric Practice 16, no. 6 (November 2010): 413–15. http://dx.doi.org/10.1097/01.pra.0000390760.12204.99.

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36

Preskorn, Sheldon H. "CNS Drug Development." Journal of Psychiatric Practice 17, no. 1 (January 2011): 49–52. http://dx.doi.org/10.1097/01.pra.0000393844.48593.82.

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37

PRESKORN, SHELDON H. "CNS Drug Development." Journal of Psychiatric Practice 20, no. 6 (November 2014): 460–65. http://dx.doi.org/10.1097/01.pra.0000456594.66363.6f.

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38

PRESKORN, SHELDON H. "CNS Drug Development." Journal of Psychiatric Practice 21, no. 1 (January 2015): 60–66. http://dx.doi.org/10.1097/01.pra.0000460622.33300.64.

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39

Kaye, Stanley B. "New drug development." European Journal of Cancer and Clinical Oncology 27, no. 3 (January 1991): 377–80. http://dx.doi.org/10.1016/0277-5379(91)90550-w.

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40

McConnell, John. "Global drug development?" Lancet 341, no. 8848 (March 1993): 822. http://dx.doi.org/10.1016/0140-6736(93)90592-5.

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41

Hoffman, Steven J., Thomas Pogge, and Aidan Hollis. "New drug development." Lancet 377, no. 9769 (March 2011): 901–2. http://dx.doi.org/10.1016/s0140-6736(11)60347-4.

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42

Catalá-López, Ferrán, Anna García-Altés, Elena Álvarez-Martín, Ricard Gènova-Maleras, and Consuelo Morant-Ginestar. "New drug development." Lancet 377, no. 9769 (March 2011): 902. http://dx.doi.org/10.1016/s0140-6736(11)60348-6.

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43

Walson, Philip D. "Pediatric Drug Development." Clinical Therapeutics 36, no. 2 (February 2014): 154–55. http://dx.doi.org/10.1016/j.clinthera.2014.01.012.

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44

Novack, Gary D. "Ophthalmic Drug Development." Journal of Glaucoma 7, no. 3 (June 1998): 202???209. http://dx.doi.org/10.1097/00061198-199806000-00009.

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45

Katz, Linda M. "Nonprescription Drug Development." Drug Information Journal 28, no. 2 (April 1994): 449–51. http://dx.doi.org/10.1177/009286159402800218.

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46

Schachter, Asher D., and Marco F. Ramoni. "Paediatric drug development." Nature Reviews Drug Discovery 6, no. 6 (May 25, 2007): 429–30. http://dx.doi.org/10.1038/nrd2333.

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47

Lakings, Duane B. "DRUG DEVELOPMENT TEAMS*." Clinical Research and Regulatory Affairs 18, no. 4 (January 2001): 329–44. http://dx.doi.org/10.1081/crp-100108180.

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48

PRESKORN, SHELDON H. "CNS Drug Development." Journal of Psychiatric Practice 23, no. 5 (September 2017): 352–60. http://dx.doi.org/10.1097/pra.0000000000000258.

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49

Turner, Mark A. "Neonatal drug development." Early Human Development 87, no. 11 (November 2011): 763–68. http://dx.doi.org/10.1016/j.earlhumdev.2011.08.014.

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50

Woodcock, J. "“Precision” drug development?" Clinical Pharmacology & Therapeutics 99, no. 2 (November 20, 2015): 152–54. http://dx.doi.org/10.1002/cpt.255.

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