Abstract
Our study focuses on the reasons for market withdrawals of drugs and drug development project terminations in clinical phases I-III from 1992 to 2002. Over 90% of the market withdrawals were caused by drug toxicity. Hepatotoxicity and cardiovascular toxicity proved to be the major causes for two out of three market withdrawals in the respective time period. In clinical phases I-III 43% of drug development project terminations were due to insufficient efficacy of the investigated compound. The second important issue, which caused one third of the projects to be closed, was toxicity. ADME parameters and economic and other reasons played a minor role. The results of our study indicate that compared with previous studies on this subject, no major improvements have been achieved in the last decade.
Keywords: market withdrawal, drug development termination, statistics
Current Pharmaceutical Design
Title: Why Drugs Fail - A Study on Side Effects in New Chemical Entities
Volume: 11 Issue: 27
Author(s): D. Schuster, C. Laggner and T. Langer
Affiliation:
Keywords: market withdrawal, drug development termination, statistics
Abstract: Our study focuses on the reasons for market withdrawals of drugs and drug development project terminations in clinical phases I-III from 1992 to 2002. Over 90% of the market withdrawals were caused by drug toxicity. Hepatotoxicity and cardiovascular toxicity proved to be the major causes for two out of three market withdrawals in the respective time period. In clinical phases I-III 43% of drug development project terminations were due to insufficient efficacy of the investigated compound. The second important issue, which caused one third of the projects to be closed, was toxicity. ADME parameters and economic and other reasons played a minor role. The results of our study indicate that compared with previous studies on this subject, no major improvements have been achieved in the last decade.
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Cite this article as:
Schuster D., Laggner C. and Langer T., Why Drugs Fail - A Study on Side Effects in New Chemical Entities, Current Pharmaceutical Design 2005; 11 (27) . https://dx.doi.org/10.2174/138161205774414510
DOI https://dx.doi.org/10.2174/138161205774414510 |
Print ISSN 1381-6128 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4286 |
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