The Stages of Drug Discovery and Development Process
DOI:
https://doi.org/10.22270/ajprd.v7i6.616Keywords:
Drug discovery, New drugs, Design, Investigations.Abstract
Drug discovery is a process which aims at identifying a compound therapeutically useful in curing and treating disease. This process involves the identification of candidates, synthesis, characterization, validation, optimization, screening and assays for therapeutic efficacy. Once a compound has shown its significance in these investigations, it will initiate the process of drug development earlier to clinical trials. New drug development process must continue through several stages in order to make a medicine that is safe, effective, and has approved all regulatory requirements. One overall theme of our article is that the process is sufficiently long, complex, and expensive so that many biological targets must be considered for every new medicine ultimately approved for clinical use and new research tools may be needed to investigate each new target. From initial discovery to a marketable medicine is a long, challenging task. It takes about 12 - 15 years from discovery to the approved medicine and requires an investment of about US $1 billion. On an average, a million molecules screened but only a single is explored in late stage clinical trials and is finally made obtainable for patients. This article provides a brief outline of the processes of new drug discovery and development.
Downloads
References
2. Smith GC, OíDonnel JT. The Process of New Drug Discovery and Development, Eds., 2nd edition, Informa Healthcare, New York 2006.
3. Moffat J, Vincent F, Lee J, Eder J, Prunotto M. Opportunities and challenges in phenotypic drug discovery: an industry perspective. Nature Reviews Drug Discovery, 2017; 16(8):531-543.
4. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. 2003, Journal of Health Economics, pp. 151-185.
5. Gashaw I, Ellinghaus P, Sommer A, Asadullah K. What makes a good drug target. Drug Discovery Today, 2012; 17:S24-S30.
6. Lindsay MA. Target discovery. Nature Reviews Drug Discovery vol. 2, 2003; pp 831–838.
7. Terstappen G, Schlüpen, C, Raggiaschi R, Gaviraghi G. Target deconvolution strategies in drug discovery. Nature Reviews Drug Discovery, 2007; 6(11):891-903.
8. Peet NP. What constitutes target validation? Targets. 2003; 2:125–127.
9. Imming P, Sinning C, Meyer A. Drugs, their targets and the nature and number of drug targets. Nature Rev Drug Discov 2006; 5:821-834.
10. Odilia Osakwe. Social Aspects of Drug Discovery, Development and Commercialization. Chapter 6 Preclinical In Vitro Studies: Development and Applicability. Elsevier. 2016.
11. Croston G. The utility of target-based discovery. Expert Opinion on Drug Discovery, 2017; 12(5):427-429.
12. Henning SW, Beste G. Loss-of-function strategies in drug target validation. Curr Drug Discov. 2002; 17–21.
13. John GH, Martyn NB, Bristol-Myers S. High throughput screening for lead discovery. Burger’s Medicinal Chemistry and Drug Discovery, sixth edition, Vol 2: Drug Discovery and Drug Development 2002, Wiley Press, pp37-70.
14. Patidar AK, Selvam G, Jeyakandan M, Mobiya AK, Bagherwal A, Sanadya G, Mehta R. Lead Discovery and lead optimization: A useful strategy in molecular modification of lead compound in analog design. International journal of drug design and discovery. 2011; 2(2):458-463.
15. Huber W. A new strategy for improved secondary screening and lead optimization using high-resolution SPR characterization of compound–target interactions. J Mol. Recogn. 2005; 18:273–281.
16. Lofas S. 2004. Optimizing the hit-to-lead process using SPR analysis. Assay Drug Devl. Technol. 2: 407–416.
17. Barile FA. Pri. nciples of Toxicological Testing. CRC Press, USA, 2008.
18. Friedman LM, Furberg CD, Demets DL. Fundamentals of clinical trials. 4th ed. New York: Springer Science and Business Media LLC; 2010.
19. Faqi AS. A comprehensive guide to toxicology in preclinical drug development. Waltham, MA: Elsevier; 2013.
20. Vogel HG. Drug Discovery and Evaluation 2nd edition. Springer, USA, 2002.
21. Karara AH, Edeki T, McLeod J, et al. PhRMA survey on the conduct of first-in-human clinical trials under exploratory investigational new drug applications. J CliPharmacol. 2010; 50:380–391.
22. Fitzpatrick S. The clinical trial protocol. Buckinghamshire: Institute of Clinical Research; 2005.
23. Kinders, Robert, et al. Phase 0 Clinical Trials in Cancer Drug Development: From FDA.
24. DiMasi J. Risks in New Drug Development: Approval success Rates for Investigational Drugs. Clinical Pharmacology & Therapeutics, 2001; 297-307.
25. Friedhoff L. New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients. New York, NY: PSPG Publishing; 2009.
26. FDA (2003). New Drug Approval Reports. http://www.fda.gov/cder/rdmt/default.htm.
27. FDA, The FDA and the Drug Development Process: How the FDA insures that drugs are safe and effective, FDA Fact sheet, 2002.
28. Adams CP, and Brantner VV. New Drug Development: Estimating entry from human clinical trials. Bureau of Economics Federal Trade Commission. 2003
Published
How to Cite
Issue
Section
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).