Communicating the Value of Pharmacodynamic Modelling in Drug ...

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…And Gemcabene A 0 = gemcabene alone A 10 = gemcabene + atorvastatin 10 mg etc. slide 30 30 May 2008, ARCS © Pharsight Corporation All Rights Reserved
Summary of process so far …. Pre-Clinical Data Safety Trials Phase II Trials Competitor Label Information Response Scientific Literature Dose Population Modeling Techniques, Model qualification The model summarizes and quantifies what is known. The model assumptions detail what is not known. PK-PD Models C(t) = D / V (Ae -αt + Be -βt ) E(t) = E 0 + (E max -E 0 ) • C(t) C(t) + EC 50 + Model Assumptions 1. 2. 3. Simulations Dimensions of Decision Space • X Endpoints • Y Drugs/Doses • Z Covariates X*Y*Z dimensions e.g.,1000 simulations/dimension = [X*Y*Z]* 10 3 data points slide 31 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 and 14: Public-Source Data ● Public-sourc
Page 15 and 16: Case Studies Example 1. How can pre
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: Results: The Model Described Mono-
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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