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Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies
Session Chair(s)
Galina Bernstein, PHD
Senior Director, Clinical Pharmacology, Scientific Affairs, PRA Health Sciences, Canada
The session explores sophisticated PK/PD modelling in NDA enabling studies such as in hepatic and renal studies conducted for labelling requirements or provides an exploration of PK/PD for early proof of concept (POC) studies which may help to progress development more quickly. Specific therapeutic areas of PK/PD models in patients may be explored. Examples of a topic may include antiviral drugs revealing a drop in viral load associated with exposure to the drug.
Learning Objective : Discuss how sophisticated studies help in early clinical research to determine if you have a winning drug; Describe how PK/PD in patients give you better information for POC decision making.
Speaker(s)
Galina Bernstein, PHD
Senior Director, Clinical Pharmacology, Scientific Affairs, PRA Health Sciences, Canada
Proof of Concept in Early Phase Studies Through PK/PD Modeling: Clinical CRO Perspective
Justin C Earp, PHD
Pharmacometric Reviewer, OCP, OTS, CDER , FDA, United States
Role of Late Phase PK/PD in Regulatory Decisions
Stephan Schmidt, PHD
Associate Director, Center for Pharmacometrics and Systems Pharmacology, University of Florida, United States
Drug-Disease Modeling Applied to Drug Development and Regulatory Decision Making
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