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PBPK Modeling to Support Clinical Pharmacology Regulatory Decision Making

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10903 New Hampshire Ave

10903 New Hampshire Avenue

Silver Spring, MD 20903

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Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making

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The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled, "Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making." The purpose of this public workshop is to: (1) discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making; (2) share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach; (3) obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and (4) discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions. This public workshop is also being conducted to satisfy one of FDA's performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD).

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10903 New Hampshire Ave

10903 New Hampshire Avenue

Silver Spring, MD 20903

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