Toxicology Testing in Drug Discovery and Development
Abstract
The primary objective of toxicology studies in the drug discovery process is to evaluate the safety of potential drug candidates. This is accomplished using relevant animal models and validated procedures. The ultimate goal is to translate the animal responses into an understanding of the risk for human subjects. To this end the toxicologist must be aware of the international guidelines for safety evaluation as well as traditional and nontraditional toxicology models. As described in this unit, the typical toxicology profile consists of safety pharmacology, genetic toxicology, acute and subchronic toxicology, absorption, distribution, metabolism, and excretion (ADME) studies, reproductive and developmental toxicity, and an evaluation of carcinogenic potential.
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Subacute and chronic toxicity studies are usually conducted in animal models using validated procedures designed to provide insight into risk for humans, and are inherent to the drug development process prior to clinical use.
“These types of studies are usually conducted in animal models using validated procedures designed to provide insight into risk for humans. These studies are inherent to the drug development process prior to clinical use.97”
From Emerging issues in probiotic safety: 2023 perspectives (2023) · cites this paper as [97]
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References 67 · Cited by 49
- Authors
- Dorato, M. A., & Buckley, L. A.
- Affiliations
- Eli Lilly (United States) (US)
- ORCID
- Buckley, Lorrene A.
- Venue
- Current Protocols in Toxicology
- Publisher
- Wiley
- Published
- 2007-02
- Volume
- 31
- Issue
- 1
- Pages
- Unit19.1-Unit19.1
- ISSN
- 1934-9254 (ISSN-L)
- 1934-9262
- OpenAlex
- W2171402781
- Cited by
- 49
- References
- 67
- Citations by year
- 2026: 4 · 2025: 8 · 2024: 9 · 2023: 6 · 2022: 1 · 2021: 3 · 2020: 1 · 2019: 3 · 2017: 1 · 2015: 2 · 2014: 6 · 2013: 1 · 2012: 2
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Current Protocols in Toxicology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Life Sciences › Immunology and Microbiology › Immunology › Immunotoxicology and immune responses
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmacological Effects and Toxicity Studies
- Keywords
- drug safety assessment, toxicology testing, drug discovery, animal models, safety pharmacology, genetic toxicology, acute toxicity, subchronic toxicity, ADME, reproductive toxicity, developmental toxicity, carcinogenicity
- MeSH terms
- Animals, Clinical Trials as Topic, Drug Evaluation, Preclinical, Humans, Models, Biological, Species Specificity, Time Factors, Drugs, Investigational, Guidelines as Topic, Toxicity Tests, Animal Use Alternatives, Marketing, Drug Discovery
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