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Modeling and simulation in dose determination for biodefense products approved under the FDA animal rule
Kimberly L Bergman1, K Krudys2, S K Seo2
1US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MA, 20933-0002, USA. kimberly.bergman@fda.hhs.gov.
Journal of Pharmacokinetics and Pharmacodynamics
|March 17, 2017
Summary
Developing medical countermeasures for biodefense requires alternative pathways like the FDA's Animal Rule. Modeling and simulation translate animal study results to determine safe and effective human doses for these critical biodefense products.
Area of Science:
- Biodefense and Public Health
- Regulatory Science
- Pharmacometrics
Background:
- Effective medical countermeasures are crucial for U.S. biopreparedness against terrorism.
- Traditional drug approval pathways are often infeasible for biodefense indications.
Purpose of the Study:
- To review the role of modeling and simulation in determining human doses for biodefense products.
- To present case studies on the utility of modeling and simulation under the FDA's Animal Rule.
Main Methods:
- Utilizing pharmacokinetic and exposure-response modeling.
- Applying modeling and simulation to translate animal efficacy data to humans.
- Leveraging the U.S. Food and Drug Administration's (FDA) Animal Rule regulatory pathway.
Main Results:
- Modeling and simulation enable the identification of human dosing regimens.
- These methods facilitate the translation of animal efficacy to expected human benefit.
- Case studies demonstrate the practical application of these techniques.
Conclusions:
- Modeling and simulation are essential tools for biodefense product development under the Animal Rule.
- These techniques support regulatory approval by bridging animal efficacy to human dosing.
- This approach is vital for ensuring U.S. biopreparedness.
Keywords:
Animal RuleAnthraxInfectious diseasesModelingPharmacodynamicsPharmacokineticsRegulatorySimulationMore Related Videos
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