Communicating the Value of Pharmacodynamic Modelling in Drug ...

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Traditionally, drug development is a lengthy and costly process. Significant increase in investment and productivity Productivity is declining A key problem is separating the winners from the losers early. slide 2 30 May 2008, ARCS © Pharsight Corporation All Rights Reserved
FDA Perspective There is a clear emerging message from the FDA regarding their view of the importance of Modelling and Simulation (M&S) to reduce the cost, time, and uncertainty in getting new medical products to patients. Critical Path White Paper (March, 2004) and Report (March, 2006)* ● Proposes utilization of model-based approaches to improve knowledge management and decision-making Guidances ● In 1999, FDA issued “Guidance for Industry | Population Pharmacokinetics” ● In 2003, FDA issued “Guidance for Industry | Exposure-response relationships: Study Design, Data Analysis, and Regulatory Applications” New focus on End-of-Phase IIa meetings *http://www.fda.gov/oc/initiatives/criticalpath/ ● Goal: Reduce unnecessary late stage (IIb, III) failures by • Review of dose vs. response models , exposure vs. response models, drug – disease models, simulations of phase IIb and preparation for phase III trial design • Review dose adjustment strategies for special populations • Review clin pharm and biopharmaceutical issues, as well as newer areas of uncertainty: QT trial design, pharmacogenomic and paediatric considerations slide 3 30 May 2008, ARCS © Pharsight Corporation All Rights Reserved
Page 1: Communicating the Value of Pharmaco
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 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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