Communicating the Value of Pharmacodynamic Modelling in Drug ...

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Model-Based Drug Development Key Considerations Goal ● Tools for computer assisted trial simulation ● Data repositories ● Standardization of tools, databases and practices ● Communicating outcomes to decision-makers ● SMALLER NUMBER OF FAILED TRIALS • Reduced cost associated with trials • Increased certainty in trial designs • Lower rate of late-stage attrition • Studies in appropriate populations slide 6 30 May 2008, ARCS © Pharsight Corporation All Rights Reserved
Examples of Applications of MBDD Historically, typical PK/PD applications include: ● What are the important determinants of drug exposure – age, weight, gender, ethnicity, renal function? Which is the most important? ● What is the relationship between exposure and the incidence of adverse events – eg nausea, fatigue, diarrhoea, major bleeds? ● What is the relationship between exposure and clinical outcome – eg change in fasting plasma glucose, LDL reduction, reduction in tumour size? slide 7 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 What Can Be Done About It?
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 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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