Population PKPD Mode.. - Pharsight Corporation

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Example of a likelihood profile -200.000 Llikelihood Likelihood profile Profile for for propafenone Covariate Effect effect -201.000 -201.581 -202.000 OFV value -203.000 -204.000 Delta OFV= 3.84 -205.000 0.167 -205.42 0.422 0.15 0.20 0.25 0.30 0.35 0.40 0.45 Propafenone Covariate Effect effect slide 48 © Pharsight Corporation All Rights Reserved
Example of predictive check Drug ROP Men 1 Men Drug ROP 1 Women Drug BUP 2 Concentrations and predictions in "mg/L" 2.0 1.5 1.0 0.5 90 % PI Cobs PRED 2.0 1.5 1.0 0.5 90 % PI Cobs PRED 2.0 1.5 1.0 0.5 90 % PI Cobs PRED 0.0 Vd/F=366 L 0.0 Vd/F=208 L 0.0 0 5 10 15 20 25 30 0 5 10 15 20 25 30 0 5 10 15 20 25 30 TIME "Hr" TIME "Hr" TIME "Hr" slide 49 © 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 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: What to use in diagnostics ? ●
Page 51: Proprietary Notice ● All contents

Population PKPD Mode.. - Pharsight Corporation

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