Experience In Using PBPK Models in Clinical Pharmacology Reviews

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Summary: Pediatric PBPK • PBPK model building requires knowledge of physiology (system) and drug disposition • Application of a pediatric PBPK model should use existing adult model and integrate/update with current knowledge in ontogeny of physiological processes • PBPK model should be continuously updated for enhanced model confidence in predicting unknown clinical situations 30
Basic steps for PBPK analyses 0. Determine Questions that may be addressed by PBPK 1. Determine Clearance Pathways (e.g., f m) 2. Build PBPK Model (Drug- and System- parameters) 3. Compare simulated profiles with in vivo data 4. Refine model 5. Predict (unlimited # of) unknown clinical settings 31
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 and 8: �Central role: to assess PKPD in
Page 9 and 10: Outline � Why PBPK � Applicatio
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: PBPK model in adults PBPK model in
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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