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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)
Proof of Concept in Early Phase Studies Through PK/PD Modeling: Clinical CRO Perspective
Galina Bernstein, PHD
PRA Health Sciences, Canada
Senior Director, Clinical Pharmacology, Scientific Affairs
Role of Late Phase PK/PD in Regulatory Decisions
Justin C Earp, PHD
FDA, United States
Pharmacometric Reviewer, OCP, OTS, CDER
Drug-Disease Modeling Applied to Drug Development and Regulatory Decision Making
Stephan Schmidt, PHD
University of Florida, United States
Associate Director, Center for Pharmacometrics and Systems Pharmacology