Population PKPD Mode.. - Pharsight Corporation

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What is RAS? Pharsight Reporting and Analysis Services (RAS) is a high quality resource for producing the clinical pharmacology study reports that are the basis of your regulatory submission document. Common Technical Document This is the RAS deliverable Module 5 Clinical Study Reports RAS is a world class organization ● Team experience on more than 400 client engagements ● Experts with Pharsight's leading PK/PD analysis and reporting software including WinNonlin®, WinNonlin AutoPilot, and other tools (e.g., NONMEM) ● Experienced in all major disease indications and development phases ● Business representatives in the United States, Europe, and Japan to serve all major drug development geographies. Module 1 Regional Info Module 4 Non-clinical Study Reports Module 3 Quality Module 2 Common Technical Document Summaries Module 1 Regional Info Module 1 Regional Info slide 10 © Pharsight Corporation All Rights Reserved
RAS Value: High Quality Clinical Pharmacology Study Reports RAS Quality Assurance processes ensure the quality from data collection through final reporting. The quality of our reports is guaranteed through the following components: ● ● ● ● Standard Operating Procedures (SOPs) for PK/PD analysis and reporting. Registered quality assurance professional in GLPs (RQAP-GLP) Use of the latest validated software for our analyses Analysis and Reports are QC'd by an Authenticator (Scientist #1), a Reviewer (Scientist #2) and by the Vice-President of RAS (Approval). Analytic Lab QA Pharsight RAS Analytic Report SOPs SOPs SOPs Acceptance Analysis Reporting Clinic QA Clinical Deviations QA QA QA Final Clinical Report to Sponsor Protocol slide 11 © 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 and 8: Who Are Pharsight Customers? This i
Page 9: Reporting and Analysis Services (RA
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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