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
… and Strategically Application of integrated drug-disease-trial models to optimize clinical development programs with respect to therapeutic potential, R&D productivity and commercial value. Trial Data Disease Model Drug Model Diverse Expertise Physiology Trial Model ‣Biology ‣Natural Progression ‣Placebo ‣Biomarker-Outcome ‣Pharmacology ‣Effectiveness ‣Safety ‣Early-Late ‣Preclinical-Healthy-Patient ‣Patient Population ‣Drop-out ‣Compliance Graphic provided courtesy of Dr. Joga Gobburu, OCP/FDA. Slide 18 © Tripos, L.P. 2011 All Rights Reserved
ROLE OF PK/PD MODELING AND SIMULATION IN INFLUENCING THE DESIGN OF EARLY CLINICAL STUDIES Slide 19 © 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: PK/PD has Matured Technically…
- 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 and 34: Perspectives • … as well as reg
- Page 35 and 36: Acknowledgements • Pharsight coll
ROLE OF PK/PD MODELING AND<br />
SIMULATION IN INFLUENCING THE<br />
DESIGN OF EARLY CLINICAL STUDIES<br />
Slide 19<br />
© Tripos, L.P. 2011 All Rights Reserved
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