Role of Quantitative Clinical Pharmacology in Guiding Drug

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FDA Pharmacometrics 2020 Strategic Goals Train 20 Pharmacometricians -Technical track -Disease track -Drug development track Implement 15 Standard Templates -Develop disease specific data, analysis standards -Expect industry to follow Develop 5 Disease Models -Create public disease model library International Harmonization -Share expertise between global regulatory bodies Integrated Quantitative CP Summary -All NDAs should have exposureresponse analyses Design by Simulation: 100% Pediatric WRs -Leverage prior knowledge to design Pediatrics Written Request trials September 24-25, 2009 OCP Ambassador Program Nitin.Mehrotra@fda.hhs.gov 36
Acknowledgements • Argatroban – Drs Madabushi, Choi, Lu, Robie- Suh, Rieves and Gobburu • Drug X- Drs Jadhav, Zhang and Gobburu • Lawrence Lesko • Jeffrey Barrett, Erin Dombrowsky, CHOP
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: Pharmacometricians are Professional
Page 39 and 40: Thank You September 24-25, 2009 OCP

Role of Quantitative Clinical Pharmacology in Guiding Drug

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