Communicating the Value of Pharmacodynamic Modelling in Drug ...

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Docetaxel exposure-response modeling was performed in 640 patients Patients with solid tumor including metastatic breast and non-small cell lung cancer Docetaxel clearance and AUCs were estimated using population PK Likelihood of tumor response (CR and PR), time to progression, survival and toxicity (grade 4 neutropenia, febrile neutropenia…) were analyzed Source: R. Bruno et al. J. Clin. Oncology 16, 187-196, 1998 slide 20 30 May 2008, ARCS © Pharsight Corporation All Rights Reserved
Docetaxel model Side effects Dose Exposure Biomarkers Tumor size dynamics Response rate Survival Progression Resistance slide 21 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: Example 2: How can M&S be used to s
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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