Communicating the Value of Pharmacodynamic Modelling in Drug ...

More documents

Recommendations

Info

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

Communicating the Value of Pharmacodynamic Modelling in Drug ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?