Communicating the Value of Pharmacodynamic Modelling in Drug ...

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Reasons for inefficiencies in clinical development … Inefficient decision making processes (poor knowledge management) ● lack of necessary information to make informed decisions ● decisions not based on quantitative inputs ● focus on the wrong areas (e.g., speed to market as opposed to understanding the dose response) ● loss of knowledge due to changes in staff and assignments ● inability to capture information (such as how and why decisions were made, intellectual property, etc.) Lack of (efficient) utilization of technology slide 4 30 May 2008, ARCS © Pharsight Corporation All Rights Reserved
…. And What Can Be Done About It? Model-Based Drug Development (MBDD) ● Rather than filling in gaps in knowledge, M&S is now being used to better design future studies and drug development programs: • Optimize clinical drug development focus on establishing exposure-response relationships to allow correct choice of dose(s) • Establish the use of drug-disease models and advanced pharmacometric concepts in early drug development • Promote the use of innovative clinical designs early in clinical development to establish proof of concept and exposure-response relationships slide 5 30 May 2008, ARCS © Pharsight Corporation All Rights Reserved
Page 1 and 2: Communicating the Value of Pharmaco
Page 3: FDA Perspective There is a clear em
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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