Population PKPD Mode.. - Pharsight Corporation

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PD Data Efficacy and Safety from PHASE II/III studies Phase I Phase II Phase III Multiple Dose Sparse PK Three Efficacy endpoints Two Safety endpoints slide 28 © Pharsight Corporation All Rights Reserved
Typical POP PK Model Development Workflow Developing the Base PK Model Structural Model How many compartments are needed for disposition ? What input function can describe the absorption ? Statistical Model Deterministic Component ⎡θ ⎤ 1 Θ= ⎢ θ ⎥ ⎢ 2 ⎥ ⎢θ ⎥ 3 ⎣ ⎦ Disposition function One-Two-or Three-compartments Non-linearities, target-mediated… Input function What random effects on parameters are needed or supported by the data ? What residual variability model to use ? Stochastic Component Between subject variability (BSV) matrix Distributional assumption (Log-normal) Full Block Full Diagonal Reduced Residual variability model Additive, proportional, combined ⎡Ω11 Ω= ⎢ ⎢ Ω Ω ⎢⎣ 0 0 ⎡σ 12 22 ⎤ 11 Σ= ⎢ 0 σ ⎥ 22 ⎣ ⎦ ⎤ ⎥ ⎥ Ω ⎥ 33 ⎦ slide 29 © 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: PK Data PK from PHASE I, II and III
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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