Role of PKPD Modeling and Simulation in Influencing ... - Pharsight
Role of PKPD Modeling and Simulation in Influencing ... - Pharsight Role of PKPD Modeling and Simulation in Influencing ... - Pharsight
Perspectives • Growing use of drug-disease-trial Modeling & Simulation will influence drug development decisions … Portfolio • Which indications should we pursue? • At what level of investment? Program • What trials should we conduct, and when? • When should we stop development? Trial • Which endpoints should we study? • Which doses and what arm sizes? Slide 32 © Tripos, L.P. 2011 All Rights Reserved
Perspectives • … as well as regulatory decisions about labeling and approval Slide 33 © 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: PERSPECTIVES Slide 31 © Tripos, L.
- Page 35 and 36: Acknowledgements • Pharsight coll
Perspectives<br />
• … as well as regulatory decisions about label<strong>in</strong>g <strong>and</strong> approval<br />
Slide 33<br />
© Tripos, L.P. 2011 All Rights Reserved
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