Why Drugs Fail in Late Stages of Development: Case Study Analyses from the Last Decade and Recommendations

Author:

Parasrampuria Dolly A.,Benet Leslie Z.,Sharma Amarnath

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference109 articles.

1. PhRMA. Modernizing Drug Discovery, Development & Approval. 2016 Mar 31. < http://www.phrma.org/report/policy-solutions-modernizing-drug-discovery-development-and-approval >.

2. Thomas DW, Burns J, Audette J, Carrol A, Dow-Hygelund C, Hay M. Clinical development success rates 2006–2015. San Diego: Biomedtracker/Washington, DC: BIO/Bend: Amplion. 2016 Jun.< https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf >.

3. Philippidis A. Top 10 clinical trial failures of 2013. Genetic Engineering & Biotechnology News. 2014 Feb 3. < http://www.genengnews.com/insight-and-intelligence/top-10-clinical-trial-failures-of-2013/77900029/?page=2 >.

4. Lowe D. Mongersen Fails. Sc Translation Med 2017. < http://blogs.sciencemag.org/pipeline/archives/2017/10/23/mongersen-fails >.

5. US Food and Drug Administration. 22 Case studies where Phase 2 and phase 3 trials had divergent results. Jan 2017. https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM535780.pdf

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