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

• Daphney Jean,
• Kunal Naik,
• Lauren Milligan,
• Stephen Hall,
• Shiew Mei Huang,
• Nina Isoherranen,
• Colleen Kuemmel,
• Paul Seo,
• Million A. Tegenge,
• Yaning Wang,
• Yuching Yang,
• Xinyuan Zhang,
• Liang Zhao,
• Ping Zhao,
• Jessica Benjamin,
• Kimberly Bergman,
• Joseph Grillo,
• Rajanikanth Madabushi,
• Fang Wu,
• Hao Zhu,
• Issam Zineh

Affiliations

Daphney Jean

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Kunal Naik

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Lauren Milligan

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Stephen Hall

Eli Lilly and Company Indianapolis Indiana USA

Shiew Mei Huang

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Nina Isoherranen

School of Pharmacy University of Washington Seattle Washington USA

Colleen Kuemmel

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Paul Seo

Office of Pharmaceutical Quality Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Million A. Tegenge

Office of Tissues and Advanced Therapies Center for Biologics Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Yaning Wang

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Yuching Yang

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Xinyuan Zhang

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Liang Zhao

Office of Generic Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Ping Zhao

Bill & Melinda Gates Foundation Seattle Washington USA

Jessica Benjamin

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Kimberly Bergman

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Joseph Grillo

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Rajanikanth Madabushi

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Fang Wu

Office of Generic Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Hao Zhu

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Issam Zineh

Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA