Experience In Using PBPK Models in Clinical Pharmacology Reviews

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Organ Dysfunction: The Interplay Effect of renal impairment on hepatic pathways Yeo, Exp Op Clin Pharmacol, 2011 16
PBPK Simulation: Renal Impairment + Moderate Enzyme Inhibitor in Elderly Rivaroxaban AUC Ratio Renal functions Normal Mild Moderate Severe No Erythromycin 1.0 a 1.4 a 1.5 a 1.6 a With Erythromycin 1.6 b 2.5 b 2.9 b 3.0 b a Observed with in older subjects b Simulated using younger subjects with normal renal function as baseline More than 2-fold AUC Ratio is considered clinically significant Sponsor chose to study the combined effect (on-going) Grillo et al, DCP5 Grillo et al, Biopharm Drug Dispo, 2012 17
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: Organ Dysfunction: The Interplay Ef
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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