Population PKPD Mode.. - Pharsight Corporation

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RAS Value: Timely Analysis with Pharsight Software RAS leverages Pharsight’s integrated software system for the analysis and storage of PK data to deliver timely, auditable and cost-effective results. WinNonlin® AutoPilot enables Pharsight’s analysts to deliver results 80% faster than other manual NCA reporting methods IVIVC Toolkit for WinNonlin® enables Pharsight’s analyst to minimize manipulation and speed-up analysis and delivery of report Grid computing facility enables Pharsight’s analyst to use CPU intensive methods (e.g. bootstrap) Sponsor Data Final Clinical Report to Sponsor WinNonlin AutoPilot WinNonlin IVIVC Toolkit Mixed effects : NONMEM VI PKS Connector PKS Reporter Pharsight Knowledgebase Suite & GLP Server slide 12 © Pharsight Corporation All Rights Reserved
RAS Offers Three Analytic Competencies RAS scientists work collaboratively with your organization using the latest technology to produce and deliver timely, high quality analytic reports. Sponsor Data Pharsight RAS Analysis 1. NCA •Preclinical •Phase I •Phase II 2. IVIVC Formulation 3. Regulatory Pop PK- PD Analysis Results Reporting 1. Writing •Scientific •Pharmacological •Medical 2. Quality Assurance 3. Formatting Clinical Study Reports slide 13 © 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 and 10: Reporting and Analysis Services (RA
Page 11: RAS Value: High Quality Clinical Ph
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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