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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An in-depth scientometric analysis of AI4DD showed a steep rise in publications, from 49 in 2011 to 333 in 2020.
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“In the analysis of drugs withdrawn for toxicity reasons in the period between 1992 and 2002, hepatotoxicity was identified in 27% of cases (36).”
BackgroundHuman embryonic stem cells: a journey beyond cell replacement therapies
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“Colonizing the lumen, the latter can be used to recapitulate structures and functional interactions of the organ of interest (Garcia et al. 2012; Schanz et al. 2010; Schuster et al. 2005; Song and Ott 2011; Stevens and Baker 2009; Uygun et al. 2010).”
BackgroundA sandwiched microarray platform for benchtop cell-based high throughput screening
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“potential targets and the current screening capabilities is confoundedby theneed to studydrugedrug interactions at the early stages of development in order to evaluate potential complications in later-stage trials.[4] Traditionally, HTS is carried out in dedicated facilities, and access is often limited by high capita…”
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Prediction of drug intestinal absorption by new linear and non-linear QSPR
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“failure of drug candidates in the clinical phases of drug development (Fung et al. 2001; Lasser et al. 2002; Shuster et al. 2005; Temple and Himmel 2002; Zimmerman 1999).”
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- 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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