Clinical Trials: Essential Stage in Development of Drug
Abstract
This article gives an idea about the clinical trials and way its importance in the development of the vaccine. The different phases which are involved in clinical trials like phase I, phase II, phase III, and phase IV. Each phase role in the development of vaccines and how clinical trials play an important role in the treatment of various diseases. The role of a clinical trial is to help society and the entire medical community by contributing to the research and development of new drugs concerning their safety and efficacy.
Keywords: Preclinical trials, phase I trial, phase II trial, phase III trial, phase IV trial
Keywords:
Preclinical trials, phase I trial, phase II trial, phase III trial, phase IV trialDOI
https://doi.org/10.22270/jddt.v12i4-S.5621References
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https://www.google.com/amp/s/www.pharmatutor.org/articles/review-on-clinical-trials-clinical-research-organization-phases-of%2520-clinical-research%3famp
2) Umscheid CA, Margolis DJ, Grossman CE, Key Concepts of clinical trials: A Narrative review, Postgrad med. 2011; 123 (5):194-204 https://doi.org/10.3810/pgm.2011.09.2475
3) Dr.A. Bhatt, Evaluation of clinical research: A history Before & Beyond James Lind, Pubmed, 2010; 1 (1):6-10
4) Pancreatic cancer UK, disadvantages of clinical trials, 2022. https://www.pancreaticcancer.org.uk/information/clinical-trials/advantages-and-disadvantages-of-clinical-trials/
5) American kidney fund, Advantages and disadvantages of participating in clinical trials,1971
https://www.kidneyfund.org/treatments/clinical-trials/advantages-and-disadvantages-participating-clinical-trials
6) Thorat SB, Banarjee SK, Gaikwad DD, Jadhav SL, Thorat RM, Clinical Trial: A Review, International Journal of pharmaceutical sciences Review and Research, 2010; 19(1):0976-044.
7) Havelmann U, pharmacoKinetic & Pharmacodynamic Characteristics of Dasiglucagon, A Novel Soluble and stable Glucagon Analog. Diabetes care, 2018; 41(3):531-537. https://doi.org/10.2337/dc17-1402
8) Tripathi KD, Essentials of Medical Pharmacology, 8th edition. New Delhi: Jaypee Brothers Medical publishers, 2019; 89-90
9) Hill TP, Conducting Phase IV Clinical Studies: A moral imperative, ecancer medical science, USA, 2012; (10):276
10) Singh K, Mehta S, The clinical development process for a novel preventive Vaccine: An Overview Journal of postgraduate medicine, 2016;2(1):9-11. https://doi.org/10.4103/0022-3859.173187
11) Ledesma P, phase 1 clinical Trials: frequently Asked questions, Sofpromed, 2020;
12) Ivy SP, Siu LL, Garrett - Mayer E, Rubinstein Larry, Approaches to phase 1 clinical trial Design focus on safety, efficiency, and selected patient populations: A Report from the clinical trial Design task Force of the national cancer Institute, AACR Journals, 2010; 16(6):1726 – 1736 https://doi.org/10.1158/1078-0432.CCR-09-1961
13) Zhang X, Zhang Y, Guo X, Jie He, Overview of phase IV Clinical Trials for Post Market drug safety surveillance: a status report from the clinical trials. gov registry, Pubmed, 6(11):e010643. https://doi.org/10.1136/bmjopen-2015-010643
14) Norman AV, phase ll trials in Drug Development & Adaptive trial Design, Pubmed, 2019; 4 (3):428-437 https://doi.org/10.1016/j.jacbts.2019.02.005
15) Understanding clinical trial terminology: What's A Phase 1,2 or 3 clinical trial? News, CONCERT Pharmaceuticals inc. 3 rd September 2019;
16) Savale sk, New Drug Application [NDA], slide share, Jun.19, 2016;
17) ANDA (Abbreviated New Drug Application), Malla Ready College of pharmacy, Sep.30, 2014;
18) How are drugs developed and approved? The drug development process Pharmacology, Hub Pages, Apr 28, 2016;
19) Department of psychiatry and behavioral Neuroscience, UC College of Medical, clinical trials phases Defined, 2010;
20) Dr. Mandal A, what is a phase 4 Clinical Trials, News, medical & Life science, 2012;
21) Clinical Trials phase objective and timeline, slide Team, 2011
Published
2022-08-15
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Tamboli S, Surwade A, Mahale K, Khairnar K, Avhad K, Avhad A, et al. Clinical Trials: Essential Stage in Development of Drug. J. Drug Delivery Ther. [Internet]. 2022 Aug. 15 [cited 2025 Nov. 14];12(4-S):210-3. Available from: https://www.jddtonline.info/index.php/jddt/article/view/5621
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How to Cite
1.
Tamboli S, Surwade A, Mahale K, Khairnar K, Avhad K, Avhad A, et al. Clinical Trials: Essential Stage in Development of Drug. J. Drug Delivery Ther. [Internet]. 2022 Aug. 15 [cited 2025 Nov. 14];12(4-S):210-3. Available from: https://www.jddtonline.info/index.php/jddt/article/view/5621
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