Experience In Using PBPK Models in Clinical Pharmacology Reviews

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PBPK: Systems Clinical Pharmacology Blood Lung Rapidly perfused organs Slowly perfused organs Kidney Liver Intestines Blood Other rapidly perfused organs Heart 6
�Central role: to assess PKPD in specific patient groups �To make more informed decision on drug dosing �To guide our decisions: Clinical Pharmacology Huang and Temple, Clin Pharmcol Ther, 2007 � In theory, all situations can be tested clinically. However, ethical and practical issues may limit the numbers of studies one can conduct � Can some situations be predicted using current knowledge? 7
Page 1 and 2: Experience In Using PBPK Models in
Page 3 and 4: Physiologically-based Pharmacokinet
Page 5: C C a,V a C, V Can Model Provide De
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 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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