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Why Drugs Fail - A Study on Side Effects in New Chemical Entities
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
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“…proper selection of the initially used pharmacological assay is underlined by the fact that lack of clinical efficacy (indicative for inappropriate pre-clinical models) is among the most important reasons for failure of novel drugs during development (Kola and Landis, 2004; Schuster et al., 2005).”
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Metadata
- Authors
- Schuster, D., Laggner, C., & Langer, T.
- Affiliations
- Universität Innsbruck (AT)
- Venue
- Current Pharmaceutical Design
- Publisher
- Bentham Science Publishers Ltd.
- Published
- 2005-10-01
- Volume
- 11
- Issue
- 27
- Pages
- 3545-3559
- ISSN
- 1381-6128 (ISSN-L)
- OpenAlex
- W2141455139
- Cited by
- 417
- References
- 0
- Citations by year
- 2026: 7 · 2025: 10 · 2024: 14 · 2023: 30 · 2022: 17 · 2021: 11 · 2020: 21 · 2019: 17 · 2018: 21 · 2017: 23 · 2016: 27 · 2015: 30 · 2014: 21 · 2013: 22 · 2012: 32
- FWCI
- 13.04
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Current Pharmaceutical Design (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Keywords
- drug failure, drug toxicity, hepatotoxicity, cardiotoxicity, adverse drug reactions, new chemical entities, drug efficacy
- MeSH terms
- Humans, Product Surveillance, Postmarketing, Drugs, Investigational, Treatment Failure, Drug-Related Side Effects and Adverse Reactions
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