Population PKPD Mode.. - Pharsight Corporation
Population PKPD Mode.. - Pharsight Corporation
Population PKPD Mode.. - Pharsight Corporation
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
PK/PD PK/PD Expertise Expertise in in Early Early Drug Drug Development<br />
1) Non-Compartmental PK/PD analysis using WinNonlin ® and AutoPilot<br />
● PK and PD analyses and creation of Tables, Figures and Listings<br />
● Statistical analyses (ANOVAs, Dose-Proportionality, Steady-State Analysis)<br />
● Draft and Final ICHE3 Clinical Study Reports<br />
● PK/PD Analysis and Report 100% QC’d by two scientists (Authenticator and Reviewer)<br />
● QA inspection performed by a Registered Quality Assurance Professional in GLPs (RQAP-GLP).<br />
Plasma Concentration (ng/mL)<br />
1.2<br />
0.6<br />
0<br />
Preclinical<br />
• TK and PK analysis in animals<br />
• Allometric Scaling<br />
Cmax<br />
Phase I<br />
• Maximum Tolerated Dose (MTD)<br />
• SAD, MAD studies<br />
• Bioequivalence/Bioavailability<br />
• Food Effect Studies<br />
• Drug-Drug Interactions<br />
• Studies in Special <strong>Population</strong>s<br />
(renal/liver impaired)<br />
• QT Prolongation Studies<br />
Phase II<br />
• Dosing Requirements Studies (IIa)<br />
• Efficacy Studies (IIb)<br />
Total drug exposure (AUC 0-inf<br />
) CL = Dose / AUCinf IV<br />
CL/F = Dose / AUCinf PO<br />
Vss = CL x MRT IV<br />
Varea/F = Dose / AUCinf x λ z<br />
PO<br />
0 24 48<br />
Time (h)<br />
slide 14<br />
© <strong>Pharsight</strong> <strong>Corporation</strong> All Rights Reserved
Change language