Population PKPD Mode.. - Pharsight Corporation

More documents

Recommendations

Info

PK/PD PK/PD Expertise Expertise in in Early Early Drug Drug Development 1) Non-Compartmental PK/PD analysis using WinNonlin ® and AutoPilot ● PK and PD analyses and creation of Tables, Figures and Listings ● Statistical analyses (ANOVAs, Dose-Proportionality, Steady-State Analysis) ● Draft and Final ICHE3 Clinical Study Reports ● PK/PD Analysis and Report 100% QC’d by two scientists (Authenticator and Reviewer) ● QA inspection performed by a Registered Quality Assurance Professional in GLPs (RQAP-GLP). Plasma Concentration (ng/mL) 1.2 0.6 0 Preclinical • TK and PK analysis in animals • Allometric Scaling Cmax Phase I • Maximum Tolerated Dose (MTD) • SAD, MAD studies • Bioequivalence/Bioavailability • Food Effect Studies • Drug-Drug Interactions • Studies in Special Populations (renal/liver impaired) • QT Prolongation Studies Phase II • Dosing Requirements Studies (IIa) • Efficacy Studies (IIb) Total drug exposure (AUC 0-inf ) CL = Dose / AUCinf IV CL/F = Dose / AUCinf PO Vss = CL x MRT IV Varea/F = Dose / AUCinf x λ z PO 0 24 48 Time (h) slide 14 © Pharsight Corporation All Rights Reserved
PK/PD Expertise in Early Drug Development 2) IVIVC analysis using WinNonlin ® Toolkit to Perform Efficient Analyses ● Modified-release formulations & super generics [505(b)2] ● Fixed-Dose Combination Products ● Drug Delivery systems (Transdermal, parenteral, microsphere, liposomes) Correlation 1 Cp (ug/ml) 1.2 0.6 0 0 30 60 time (hr) In Vivo Release (%) Fastest Fast 0 Medium Slow 0 0.5 1 In Vitro Release (%) 0.5 Percent Dissolved 100% 50% 0 Fastest Fast Medium Slow 0 150 300 time (min) In Vivo In Vitro slide 15 © 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: RAS Offers Three Analytic Competenc
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 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

Create successful ePaper yourself

Delete template?

Save as template?