Population PKPD Mode.. - Pharsight Corporation

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RAS Typical Population Pharmacokinetics Workflow Sponsor Data Analytic Lab QA Locked SAS Dataset(s) (CDISC) Analytic Report dm.sas7bdat cm.sas7bdat RAS Protocol Sponsor ra.sas7bdat QA ex.sas7bdat Clinic pp.sas7bdat Clinical Deviations ………….. ………….. ………….. ………….. ………….. Work Plan Protocol Import Data Merge Transform ….. Exploratory graphs Detect outliers … Analysis 1. NCA •Preclinical •Phase I •Phase II Reporting 1. Writing •Scientific •Pharmacological •Medical 2. IVIVC Formulation 2. Quality Assurance Dataset construction 3. Regulatory Pop PK- PD Analysis Results 3. Formatting Clinical Study Reports slide 20 © Pharsight Corporation All Rights Reserved
Workflow: Population PK Analysis Part I (Dataset) SAS Dataset(s) from Locked Clinical Database NONMEM Dataset Construction QC Double-Coding or Construction/ Deconstruction QA NONMEM Dataset Ready for Pop PK/PD Analysis slide 21 © 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 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: RAS Regulatory PK-PD Modeling RAS s
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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