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Regulatory & Access Resources

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Leveraging the draft FDA Guidance on PBPK for your drug development program

In October of 2020, the Food and Drug Administration (FDA) issued draft guidance for the pharmaceutical industry on The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls. The draft guidance offers several high-level workflows that include defining the objective of a PBPK model, model development including structure, assumptions and parameterization, model validation, and the critical step of application of the model to purpose. The guidance is only applicable for biopharmaceutics applications of orally administered drugs.