Population PKPD Mode.. - Pharsight Corporation

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Typical POP PK Model Development Workflow Developing a Covariate Model : Examples of Covariates •Demographics ● Sex, Race, Size (weight, height, BSA, IBW, BMI, …) •Lab values ● Renal function : Serum creatinine ● Liver: bilirubin, albumin, AST, ALT, … ● pheno/genotype Disease severity, Co-medication, smoking etc. slide 34 © Pharsight Corporation All Rights Reserved
Summary of Model building Absorption Model Disposition Model ⎡θ1 ⎤ ⎢ θ ⎥ Θ= ⎢ 2 ⎥ ⎢⎣ θ ⎥ 3 ⎦ Deterministic Component ⎡Ω11 Ω= ⎢ ⎢ Ω Ω ⎢⎣ 0 0 12 22 ⎡σ Ω 33 ⎤ ⎥ ⎥ ⎥⎦ ⎤ 11 Σ= ⎢ 0 σ ⎥ 22 ⎣ Between subject variability Matrix ⎦ Residual error model Stochastic Component Covariate Model Building Base Model slide 35 © 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 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: Model Building : Adding Covariates
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

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