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Monday, June 19 • 11:00am - 12:15pm
#124: Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Galina Bernstein, PhD


Proof of Concept in Early Phase Studies Through PK/PD Modeling: Clinical CRO Perspective
Galina Bernstein, PhD

Role of Late Phase PK/PD in Regulatory Decisions
Justin C Earp, PhD

Drug-Disease Modeling Applied to Drug Development and Regulatory Decision Making
Stephan Schmidt, PhD

avatar for Galina Bernstein

Galina Bernstein

Director of Pharmacometrics, Early Phase, INC Research
Dr Galina Bernstein received PhD in Biochemistry from Moscow State University, postdoctoral training from College of Pharmacy, U of Michigan, and pharmacokinetics training at Pfizer GRD PDM department. She has 15+ years’ experience in analytics, PK and PK/PD modeling for IVD, small... Read More →


Justin Earp

Pharmacometric Reviewer, OCP, OTS, CDER, FDA
Dr. Earp received his BS in Biochemistry from the University of Arizona, Tucson in May 2002. In 2008, Dr. Earp received his doctorate in pharmaceutical sciences from SUNY at Buffalo and then joined the Division of Pharmacometrics in the Office of Clinical Pharmacology, US FDA where... Read More →

Stephan Schmidt

Associate Director, Center for Pharmacometrics and Systems Pharmacology, University of Florida
Dr. Schmidt is an Assistant Professor & Associate Director of the Center for Pharmacometrics and Systems Pharmacology in Lake Nona (Orlando). Dr. Schmidt serves as the Chair of the Special Interest Groups on Systems Pharmacology of the International Pharmaceutical Federation (FIP... Read More →

Monday June 19, 2017 11:00am - 12:15pm CDT
S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Session