Cited by 417Pharmacovigilance and Adverse Drug ReactionsStatistical Methods in Clinical TrialsPharmaceutical Economics and Policy

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Why Drugs Fail - A Study on Side Effects in New Chemical Entities

Schuster, D., Laggner, C., Langer, T.·2005·Current Pharmaceutical Design

DOI 10.2174/138161205774414510

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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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Authors: Schuster, D., Laggner, C., & Langer, T.
Affiliations: Universität Innsbruck (AT)
ORCID: Schuster, D.
Laggner, C.
Langer, T.
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)
DOI: 10.2174/138161205774414510
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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