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GUIDANCE DOCUMENT

The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Draft Guidance for Industry September 2020

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2020-D-1517
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by sponsors of investigational new drug applications, and applicants for new drug applications, or abbreviated new drug applications, and supplements to these applications,  for oral drug product development, manufacturing changes, and controls. PBPK analyses use models and simulations that combine physiology, population, and drug substance and product characteristics to mechanistically describe the pharmacokinetic (PK) and/or pharmacodynamic behaviors of a drug product.

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All written comments should be identified with this document's docket number: FDA-2020-D-1517.

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