Communicating the Value of Pharmacodynamic Modelling in Drug ...

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An example of an approach used to predict doseresponse for a new drug using public-source data = competitor and analogues = NCE Commercial Efficacy/ Safety Clinical Utility Phase 2/3 public trials Biomarkers Efficacy/ Safety Dose PK Biomarkers Efficacy/ Safety Clinical Utility Phase I PKPD data slide 14 30 May 2008, ARCS © Pharsight Corporation All Rights Reserved
Case Studies Example 1. How can preclinical data be used to support dose selection for a FIM study? Example 2: How can M&S be used to support labelling? Example 3: What is the product profile of an NCE versus competing therapies ? slide 15 30 May 2008, ARCS © Pharsight Corporation All Rights Reserved
Page 1 and 2: Communicating the Value of Pharmaco
Page 3 and 4: FDA Perspective There is a clear em
Page 5 and 6: …. And What Can Be Done About It?
Page 7 and 8: Examples of Applications of MBDD Hi
Page 9 and 10: PK/PD applications in MBDD ● Mid-
Page 11 and 12: To simulate drug development scenar
Page 13: Public-Source Data ● Public-sourc
Page 17 and 18: Comparisons across regimens and dru
Page 19 and 20: Example 2: How can M&S be used to s
Page 21 and 22: Docetaxel model Side effects Dose E
Page 23 and 24: There was a clinically meaningful i
Page 25 and 26: Contribution of this approach to fi
Page 27 and 28: Strategy: Efficient Model-Based Dev
Page 29 and 30: Results: The Model Described Mono-
Page 31 and 32: Summary of process so far …. Pre-
Page 33 and 34: Models provide answers to important
Page 35 and 36: Our purpose is to view and query mo
Page 37 and 38: Q1: What is the probability that ge
Page 39 and 40: Q2: What is the probability that, i
Page 41 and 42: Q3: Given the magnitude of LDL-C lo
Page 43 and 44: Value of MBDD approach for gemcaben

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