Communicating the Value of Pharmacodynamic Modelling in Drug ...

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Example 1. How can preclinical data be used to support dose selection for a FIM study? Allometric scaling was used to predict human pharmacokinetics. Preclinical PK/PD data from cynomolgous monkey, relative potency information and literature data was used for simulation. A range of doses (30-fold), regimens (QD and BID) and bioavailability fractions (5 to 50%) were used to project human PK vs. response profiles The combination of dose and bioavailability ranges was chosen to compensate for any misspecification due to projection method or underlying assumptions. Target therapeutic range was determined using publicly available literature for three comparators. slide 16 30 May 2008, ARCS © Pharsight Corporation All Rights Reserved
Comparisons across regimens and drugs showed a favourable predicted response 0 100 200 300 %Time in Th. Window 80 60 40 20 0 Multiple BID Multiple QD 0 100 200 300 Dose (mg/day) slide 17 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: Case Studies Example 1. How can pre
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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