Experience In Using PBPK Models in Clinical Pharmacology Reviews

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PBPK: Predict, Learn, and Confirm A. Patient Factors Intrinsic factors Extrinsic factors Huang and Temple, 2008 Adapted from Zhao P, et al Clin Pharmacol Ther 2011 System component (drug-independent) Predict, Learn, Confirm B. PBPK Model components Physiology Anatomy Biology PBPK Model Drug-dependent component Drug disposition Drug action 8
Outline � Why PBPK � Application of PBPK in clinical pharmacology review 9
Page 1 and 2: Experience In Using PBPK Models in
Page 3 and 4: Physiologically-based Pharmacokinet
Page 5 and 6: C C a,V a C, V Can Model Provide De
Page 7: �Central role: to assess PKPD in
Page 11 and 12: Interacting drug ADME, PK, PD and M
Page 13 and 14: Fesoterodine case Polymorphic vs No
Page 15 and 16: Organ Dysfunction: The Interplay Ef
Page 17 and 18: PBPK Simulation: Renal Impairment +
Page 19 and 20: DDI Caused by Dose- and Time-depend
Page 21 and 22: Study Design Should inhibitor and s
Page 23 and 24: Model-based Design of Clinical PK S
Page 25 and 26: Pediatrics Geriatrics Pregnancy The
Page 27 and 28: Clearance Prediction Needs To Be Ta
Page 29 and 30: PBPK model in adults PBPK model in
Page 31 and 32: Basic steps for PBPK analyses 0. De
Page 33 and 34: Acknowledgements FDA Office of Clin
Page 35: The Need to Consider Metabolites in

Experience In Using PBPK Models in Clinical Pharmacology Reviews

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