Population PKPD Mode.. - Pharsight Corporation

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Today’s Presenter Dan Weiner ● ● ● ● ● ● ● Expert consultant to the U.S. Food and Drug Administration (FDA) Executive sponsor for Pharsight’s Cooperative Research and Development Agreement (CRADA) with FDA Senior positions at Merrell-Dow, Syntex, Quintiles, IVAX and Pharsight Trained over 1000 scientists in PK/PD modeling Original author of WinNonlin® Coauthor of Pharmacokinetic & Pharmacodynamic Data Analysis: Concepts and Applications PhD in Mathematical Statistics slide 2 © Pharsight Corporation All Rights Reserved
Agenda Pharsight Company Overview Reporting and Analysis Services (RAS) ● ● Expertise, Workflow and Communication Plan Regulatory Population Pharmacokinetics Workflow Case Study: Population PK/PD to Support NDA Submission Model Building: Adding Covariates Model Discrimination, Evaluation and Diagnosis slide 3 © Pharsight Corporation All Rights Reserved
Page 1: Population PK/PD Modeling - The Pha
Page 5 and 6: Who Is Pharsight? A company that he
Page 7 and 8: Who Are Pharsight Customers? This i
Page 9 and 10: Reporting and Analysis Services (RA
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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