Role of Quantitative Clinical Pharmacology in Guiding Drug

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Acknowledgements Pharmacometrics @ FDA • Argatroban – Drs Madabushi, Choi, Lu, Robie- Suh, Rieves and Gobburu • Drug X- Drs Jadhav, Zhang and Gobburu • Lawrence Lesko • Jeffrey Barrett, Erin Dombrowsky, CHOP
Thank You September 24-25, 2009 OCP Ambassador Program Nitin.Mehrotra@fda.hhs.gov 39
Page 1 and 2: Role of Quantitative Clinical Pharm
Page 3 and 4: Pharmacometrics in Drug Development
Page 5 and 6: Why Model ? Leverage the informatio
Page 7 and 8: Quantitative Disease-Drug-Trial Mod
Page 9 and 10: September 24-25, 2009 OCP Ambassado
Page 11 and 12: Active History to Obtain Good Quali
Page 13 and 14: Pediatric Exclusivity Program is La
Page 15 and 16: Case Study: PK/PD based dosing reco
Page 17 and 18: The Data • Pediatric patients rec
Page 19 and 20: PK is Well Characterized in Pediatr
Page 21 and 22: Simulations to Explore Optimum Dosi
Page 23 and 24: Impact of Modeling • Label update
Page 25 and 26: The Issue: Antihypertensive Trial F
Page 27 and 28: The Data: Clinical Trial Simulation
Page 29 and 30: The Approach: Conceptual CTS framew
Page 31 and 32: CTS Allowed Quantitative Evaluation
Page 33 and 34: Modeling and Simulation Tool Box
Page 35 and 36: Pharmacometricians are Professional
Page 37: Acknowledgements • Argatroban - D

Role of Quantitative Clinical Pharmacology in Guiding Drug

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