Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug..
Please don't forget to share our video if you liked it. We want to grow it together. Stay healthy.

Chapters
0:00 Intro
0:16 Paracelsus
0:54 Chemical Entity
1:10 Pre-clinical Stages
3:10 Phase I
3:29 Phase II
3:38 Phase III
3:55 Phase IV
4:36 Thalidomide Disaster
5:38 Failures
6:15 Statistics
6:36 Cost
9:00 Next Video
9:14 Outro

Credits
Written Sources
Taylor, David (2015). "The Pharmaceutical Industry and the Future of Drug Development". Issues in Environmental Science and Technology. Royal Society of Chemistry: 1–33. doi:10.1039/9781782622345-00001. ISBN 978-1-78262-189-8.
Kessler, David A.; Feiden, Karyn L. (1995). "Faster Evaluation of Vital Drugs". Scientific American. 272 (3): 48–54. Bibcode:1995SciAm.272c..48K. doi:10.1038/scientificamerican0395-48. PMID 7871409.
Ciociola AA; et al. (May 2014). "How drugs are developed and approved by the FDA: current process and future directions". Am J Gastroenterol. 109 (5): 620–3. doi:10.1038/ajg.2013.407. PMID 24796999.
Miseta, Ed (August 17, 2018). "Gene Therapies Create Moral Dilemma For Clinical Researchers". Clinical Leader. Pennsylvania, United States: VertMarkets, Inc.
Prasad, Vinay; Mailankody, Sham (1 October 2017). "Research and development spending to bring a single cancer drug to market and revenues after approval". JAMA Internal Medicine. 177 (11): 1569. doi:10.1001/jamainternmed.2017.3601. ISSN 2168-6106. PMC 5710275. PMID 28892524.
Moore, Thomas J.; Zhang, Hanzhe; Anderson, Gerard; Alexander, G. Caleb (1 October 2018). "Estimated costs of pivotal trials for novel therapeutic agents approved by the US Food and Drug Administration, 2015-2016". JAMA Internal Medicine. 178 (11): 1451. doi:10.1001/jamainternmed.2018.3931. ISSN 2168-6106. PMC 6248200. PMID 30264133.
Sertkaya, A; Wong, H. H.; Jessup, A; Beleche, T (2016). "Key cost drivers of pharmaceutical clinical trials in the United States". Clinical Trials. 13 (2): 117–26. doi:10.1177/1740774515625964. PMID 26908540.
Herper, Matthew (11 August 2013). "The Cost Of Creating A New Drug Now $5 Billion, Pushing Big Pharma To Change". Forbes, Pharma & Healthcare. Retrieved 17 July 2016.
Nielsen, Nicolaj Hoejer "Financial valuation methods for biotechnology", 2010. "Archived copy" (PDF). Archived from the original (PDF) on 2012-03-05. Retrieved 2014-11-25.
Stratmann, Dr. H.G. (September 2010). "Bad Medicine: When Medical Research Goes Wrong". Analog Science Fiction and Fact. CXXX (9): 20.
"Critical Path Initiative". US Food and Drug Administration. 23 April 2018. Retrieved 24 January 2020.
"Breakthrough Therapy". US Food and Drug Administration. 4 January 2018. Retrieved 24 January 2020.
"R&D costs are on the rise". Medical Marketing and Media. 38 (6): 14. June 1, 2003. Archived from the original on October 18, 2016.
"Clinical Development Success Rates 2006-2015" (PDF). BIO Industry Analysis. June 2016.
Wang Y. (2012). "Extracting Knowledge from Failed Development Programmes". Pharm Med. 26 (2): 91–96. doi:10.1007/BF03256897.

// Visual Sources - Special Thanks //
See page for author / CC BY ([ Ссылка ]) [ Ссылка ]
Von Stephencdickson - Eigenes Werk, CC BY-SA 4.0, [ Ссылка ]
By Niko von Glasow - Niko von Glasow, CC BY-SA 2.0, [ Ссылка ]
By Unknown author - Moved from Wikipedia [ Ссылка ]. Original Source: [ Ссылка ], Public Domain, [ Ссылка ]

Polina Tankilevitch's video on Pexels
Tom Fisk's video on Pexels
bruce lam's video on Pexels
Kelly Lacy's video on Pexels
Derwin Edwards's video on Pexels
Engin Akyurt's video on Pexels
Stef's video on Pexels
Pressmaster's video on Pexels
Tom Fisk's video on Pexels
Anthony's video on Pexels
cottonbro's video on Pexels
Free Videos' video from Pexels
Polina Tankilevitch's video on Pexels
cottonbro's video on Pexels
cottonbro's video on Pexels
Duca Imagens's video on Pexels
Pixabay's video on Pexels

Cover- Pixabay's Photo on Pexels...

свернуть