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Non-clinical combination toxicology studies: strategy, examples and future perspective.
Aida Sacaan1, Satoko Nonaka Hashida2, Nasir K Khan1
1Drug Safety Research and Development, Pfizer, Inc., USA.
The Journal of Toxicological Sciences
|July 3, 2020
Summary
Assessing combination drug safety requires a tailored approach, considering factors like existing data and potential interactions. Health Authorities support case-by-case evaluations for novel therapies.
Area of Science:
- Pharmaceutical Development
- Drug Safety Assessment
- Regulatory Science
Background:
- Combination drug development is accelerating for challenging diseases.
- Safety assessment is critical before human clinical trials.
- Industry surveys and Health Authority feedback emphasize tailored safety strategies.
Purpose of the Study:
- To present Pfizer's approach to combination drug safety assessment.
- To outline key considerations for evaluating combination products.
- To highlight therapeutic area-specific strategies.
Main Methods:
- Review of existing clinical safety data for individual compounds.
- Assessment of common target organs and potential drug-drug interactions.
- Consideration of routes of administration and disease indications.
Main Results:
- No universal approach fits all combination products.
- Anti-cancer drug combinations may not require formal toxicity studies.
- Non-cancer combination safety studies typically range from 2-13 weeks in rodents.
Conclusions:
- A case-by-case strategy, guided by scientific rationale, is optimal.
- Close collaboration with Health Authorities is essential for designing safety studies.
- Tailored safety evaluations ensure the responsible development of combination therapies.
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