Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary

Affiliations

• ¹ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ² Eli Lilly and Company, Indianapolis, Indiana, USA.
• ³ School of Pharmacy, University of Washington, Seattle, Washington, USA.
• ⁴ Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁵ Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁶ Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁷ Bill & Melinda Gates Foundation, Seattle, Washington, USA.