Population PKPD Mode.. - Pharsight Corporation

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Where Is Our Strategic Focus? We provide tools and services that help our customers increase drug development efficiency, with a particular focus on the decisions occurring within the FDA’s “critical path.” The Critical Path Average time and cost per approved compound:8 years and $524M 1,2 slide 8 5000 250 5 1 Discovery Pre-Clinical Clinical Approval $23B 1 Dimasi, et al, "The price of innovation: new estimates of drug development costs," Journal of Health Economics, 22:2, March 2003 2 2005 PAREXEL R&D Statistical Sourcebook from Bain and In Vivo 3 2002 Estimated Global Pharma and Biotech R&D Spending by Category: BioPharm International, March 2003 4 PhRMA 2003 Industry Profile, March 2003 © Pharsight Corporation All Rights Reserved $48B except where noted all numbers are estimates for industry totals per year 3,4
Reporting and Analysis Services (RAS): Expertise, Workflow and Communication Plan © Pharsight Corporation All Rights Reserved
Page 1 and 2: Population PK/PD Modeling - The Pha
Page 3 and 4: Agenda Pharsight Company Overview R
Page 5 and 6: Who Is Pharsight? A company that he
Page 7: Who Are Pharsight Customers? This i
Page 11 and 12: RAS Value: High Quality Clinical Ph
Page 13 and 14: RAS Offers Three Analytic Competenc
Page 15 and 16: PK/PD Expertise in Early Drug Devel
Page 17 and 18: Communication Model: Single-Point C
Page 19 and 20: RAS Regulatory PK-PD Modeling RAS s
Page 21 and 22: Workflow: Population PK Analysis Pa
Page 23 and 24: QC/QA of the Analysis Dataset SAS D
Page 25 and 26: Regulatory and Timely POP PK/PD Pha
Page 27 and 28: PK Data PK from PHASE I, II and III
Page 29 and 30: Typical POP PK Model Development Wo
Page 31 and 32: Examples of GOF Plots Covariance ne
Page 33 and 34: Model Building : Adding Covariates
Page 35 and 36: Summary of Model building Absorptio
Page 37 and 38: Typical POP PK Model Development Wo
Page 39 and 40: Examples of Graphs to Aid Covariate
Page 41 and 42: Model Discrimination, Evaluation an
Page 43 and 44: What Can We Evaluate ? • The diff
Page 45 and 46: When to use diagnostics ? ● ●
Page 47 and 48: What to use in diagnostics ? ●
Page 49 and 50: Example of predictive check Drug RO
Page 51: Proprietary Notice ● All contents

Population PKPD Mode.. - Pharsight Corporation

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