Experience In Using PBPK Models in Clinical Pharmacology Reviews

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Conclusions • PBPK models can be applied to quantitatively evaluate intrinsic and/or extrinsic factors ̶ Provide full PK profiles of substrate and interacting drug - DDI ̶ Assess effect of multiple factors ̶ Optimize study design and data analysis ̶ Identify knowledge gaps ̶ Generate hypotheses (for further studies) • It is important to integrate knowledge in mechanisms of DDI and drug disposition, and the effect of organ impairment • It is important to understand the interplay of the intrinsic/extrinsic factors • PBPK model can be continuously updated for enhanced model confidence in predicting unknown clinical situations 32
Acknowledgements FDA Office of Clinical Pharmacology Scientific Interest Group (PBPK-SIG) - Formed March 2009 - Steering committee:, Drs. Joe Grillo, Lei Zhang, Ping Zhao - Dr. Manuela Vieira (University of Florida, FDA Critical Path Fellow) - Mentors: Drs. Shiew-Mei Huang and Larry Lesko External collaborators Professors Sandy Pang (Toronto), Amin Rostami-Hodjegan (Manchester), Yuichi Sugiyama (Tokyo), and Malcolm Rowland (Manchester); Dr. Eva Gil Berglund (EMA-MPA); Drs. Karen Rowland-Yeo and Masoud Jamei (SimCYP) 33
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Experience In Using PBPK Models in Clinical Pharmacology Reviews

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