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Printable Handouts
Navigable Slide Index
- Introduction
- Overview
- Objectives of general toxicology studies
- Toxicology studies regulations and guidance
- Good laboratory practices (GLPs)
- GLP definition
- ICH background
- ICH guidance documents
- ICH safety guidance documents
- The core toxicology guidance: ICH M3 (R2)
- Acute, subchronic, and chronic toxicity testing
- Clinical trials study duration
- Toxicology study duration
- History of acute study requirements
- Acute study components
- Subchronic studies
- Chronic studies
- Subchronic/chronic study components
- Traditional progression of repeat-dose studies
- Alternative progression of repeat-dose studies
- Why not choose the "one less study" path?
- Study design considerations
- Factors to consider before animal studies
- Dose selection of novel compounds
- Limit dose for general toxicity studies
- Small vs. large molecules: general toxicology (1)
- Small vs. large molecules: general toxicology (2)
- Key takeaway messages
Topics Covered
- Purpose of acute, subchronic, and chronic general toxicology testing
- Regulations and guidelines on conduct
- Considerations and components to consider during study design
- Differences between small and large molecule toxicology study designs
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Talk Citation
Ruppert, G. (2022, April 12). Acute, subchronic, and chronic toxicity testing [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 14, 2024, from https://doi.org/10.69645/MXUD7444.Export Citation (RIS)
Publication History
Financial Disclosures
- Mr. Gregory Ruppert has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.