Drug-mediated toxicity: illuminating the ‘bad’ in the test tube by means of cellular assays?
Abstract
Health problems are rising worldwide, be it as a consequence of lifestyle and longevity in increasingly affluent societies or due to a sharp rise in bacterial antibiotic resistance. The pharmaceutical industry is caught between high rates of attrition and the rather slow pace of a historically large regulatory system for pharmacological safety. Meanwhile, the past decade has seen a tremendous evolution of the biological toolbox, most notably of cellular assays, stem-cell differentiation and organ-mimicking systems. These systems were readily adapted for lead-compound identification. However, their use as toxicological test systems is lagging behind, not least because of a lack of regulatory acceptance. This review tries to elucidate the scale of the problem and discusses the applicability of the assays currently available, with particular regard to the use of stem cells.
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Animal studies remain the gold standard for preclinical study.
“and this remains the gold standard for preclinical study.3,4)”
From Cryopreservation of Hepatocyte Organoid-Derived Cells Generated from Human iPS Cells (2025) · cites this paper as [3]
Cites
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Lessons learned from the fate of AstraZeneca's drug pipeline: a five-dimensional framework
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Cryopreservation of Hepatocyte Organoid-Derived Cells Generated from Human iPS Cells
Nagai, W., Inui, J., Ueyama-Toba, Y., Asano, R., & Mizuguchi, H. (2025) · Biological and Pharmaceutical Bulletin · doi:10.1248/bpb.b25-00276 · Cited by 1 · see citing works
- Authors
- Tralau, T., & Luch, A.
- Affiliations
- German Federal Institute for Risk Assessment (BfR) (DE)
- Venue
- Trends in Pharmacological Sciences
- Publisher
- Elsevier BV
- Published
- 2012-07
- Volume
- 33
- Issue
- 7
- Pages
- 353-364
- ISSN
- 0165-6147 (ISSN-L)
- OpenAlex
- W1963799623
- Cited by
- 24
- References
- 5
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 1 · 2021: 2 · 2020: 1 · 2019: 1 · 2018: 1 · 2017: 4 · 2016: 3 · 2015: 2 · 2014: 1 · 2013: 2 · 2012: 3
- FWCI
- 0.59
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Trends in Pharmacological Sciences (publishedVersion)
- PubMed (publishedVersion)
- OpenAgrar (submittedVersion)
- Topics
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Life Sciences › Immunology and Microbiology › Immunology › Immunotoxicology and immune responses
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Keywords
- cell-based assays, stem cell differentiation, in vitro toxicology, regulatory acceptance, lead compound identification, alternatives to animal testing
- MeSH terms
- Animals, Biological Assay, Cells, Cultured, Drug Evaluation, Preclinical, Humans, Drug Approval, Toxicity Tests, Cell Culture Techniques, Models, Animal, Mice, Drug-Related Side Effects and Adverse Reactions
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