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Printable Handouts
Navigable Slide Index
- Introduction
- Scope of presentation
- Why toxicology testing?
- Role of safety assessment in drug development
- Goals of nonclinical testing (1)
- Goals of nonclinical testing (2)
- Goals of nonclinical testing (3)
- Key scientific disciplines within toxicology
- Types of toxicology studies
- Deciding what studies to perform
- Regulation on non-clinical safety studies
- ICH safety guidelines
- Nonclinical safety guidelines for vaccines
- Toxicology studies for first-in-human clinical trials
- Genetic toxicology
- Safety pharmacology studies - in vitro
- Safety pharmacology studies - in vivo
- General toxicology studies
- Toxicology studies for late clinical development
- Developmental and reproductive toxicology
- Carcinogenicity studies
- Nonclinical studies for marketing approval
- Biologics as different class of pharmaceuticals
- Regulation of biologics
- Increasing levels of molecular complexity
- Safety evaluation of biologics (1)
- Safety evaluation of biologics (2)
- Safety evaluation of biologics (3)
- Are animal studies predictive of clinical outcome?
- Summary
- Acknowledgements
Topics Covered
- Toxicology studies of drug candidates as a critical part of safety evaluation in non-clinical and clinical development of new medicines
- Goals, types and extent of toxicity studies in different phases of drug development
- Comparison of small chemical drugs and large therapeutic molecules (biopharmaceuticals)
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Talk Citation
Herzyk, D. (2010, August 9). Overview of non-clinical safety assessment in drug development [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 16, 2024, from https://doi.org/10.69645/CKKW9348.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Danuta Herzyk has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.