Population PKPD Mode.. - Pharsight Corporation

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Different Steps to Generate an Analysis Ready Dataset Understand the design Protocol Read and understand the timeline of the protocol Schedule of Visits Schedule of Doses Schedule of PK/PD observations Administration data PK observations data Demographic and lab data (time independent) Randomization data Demographic and lab data (time dependent) These files are merged to create an analysis dataset slide 22 © Pharsight Corporation All Rights Reserved
QC/QA of the Analysis Dataset SAS Dataset(s) from Locked Clinical Database Import Data Merge Transform ….. Exploratory graphs Detect outliers … dm.sas7bdat cm.sas7bdat ra.sas7bdat ……………. Locked Dataset Ready for Pop PK Analysis Dataset construction Pharsight Scientist 1 Construction of Dataset 1 Authenticator Print and sign scripts verify … slide 23 Pharsight Scientist 2 Deconstruction of Dataset 1 Construction of Dataset 2 QC Quality Control (Comparison) QA • Comparison of deconstructed Verification of Quality Dataset with source SAS files Control, Comparison • Comparison of the two datasets and Reconciliation and reconciliation QA Reviewer Comments QC QA QA Comments © Pharsight Corporation All Rights Reserved Quality Assurance
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 and 20: RAS Regulatory PK-PD Modeling RAS s
Page 21: Workflow: Population PK Analysis Pa
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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