Role of PKPD Modeling and Simulation in Influencing ... - Pharsight

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FDA’s Vision for Modeling and Simulation … Our Vision Too • Develop Pharmacometricians’ Core Expertise ―[…] master several fundamental PK, clinical pharmacology, and statistical concepts and develop the tools to implement these concepts.‖ • Technical Track ―Develop in-depth skills and knowledge of [various forms of] modeling.‖ • Disease Track ―Advanced knowledge of particular disease areas‖ • Drug Development Track ―Advanced knowledge of drug development — specifically how decisions are made‖ • Develop Data and Analysis Standards for 15 Indications ― […] availability of efficient tools to create and manage knowledge‖ ― Development of more integrated software is critical to industrialize pharmacometric projects‖ Gobburu JVS, Clin Pharmacol Ther 2010, 50:151S-157S. Slide 34 © Tripos, L.P. 2011 All Rights Reserved
Acknowledgements • Pharsight colleagues • Tim J. Carrothers • Farkad Ezzet • Helen Kastrissios • Adam Rutkin • Jon Wagg Slide 35 © Tripos, L.P. 2011 All Rights Reserved
Page 1 and 2: Role of PKPD Modeling and Simulatio
Page 3 and 4: A Brief History of PK/PD THE LATE 6
Page 5 and 6: 1968: Was it a Premature Birth? •
Page 7 and 8: 1979: A Rebirth Lewis Sheiner and c
Page 9 and 10: 80’s: Toddling Growing use of PK/
Page 11 and 12: A Brief History of PK/PD THE 90’S
Page 13 and 14: 90’s: The Advent of Mechanism-Bas
Page 15 and 16: A Brief History of PK/PD PK/PD TODA
Page 17 and 18: PK/PD has Matured Technically…
Page 19 and 20: ROLE OF PK/PD MODELING AND SIMULATI
Page 21 and 22: Case Study 1: Transitioning from Pr
Page 23 and 24: Event Probability (%) 0 10 20 30 40
Page 25 and 26: Case Study 1: Transitioning from Pr
Page 27 and 28: Case Study 2 — Step 1: Model Diab
Page 29 and 30: Case Study 2 —Step 3: Match entry
Page 31 and 32: PERSPECTIVES Slide 31 © Tripos, L.
Page 33: Perspectives • … as well as reg

Role of PKPD Modeling and Simulation in Influencing ... - Pharsight

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