• Section Affiliations
  • Clinical Pharmacology & Translational Research (CPTR)
  • Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM)
• Goals & Objectives
• Leadership
• Presentations

Vision:

Population approaches are an integral part of modeling and simulation techniques used in drug development.

Mission:

The PopPKPD FG fosters the advancement of quantitative modeling and simulation techniques where the PKPD experimental unit of interest is the population, through education and scientific programming, and provides an interdisciplinary forum for scientist and trainees interested in these analysis techniques.

Goals & Objectives:

• Provide a continuous stream of programming proposals for the AAPS annual meeting, as well as other educational events, related to the technical aspects of population analyses
• Facilitate an interdisciplinary scientific exchange on technical aspects of population analyses
• Create a set of common standards and requirements for the application of M&S analysis tools to populations, including their validation/qualification
• Provide a scientific platform for cutting-edge research related to the development, refinement and evaluation of pharmacometric methodologies supporting population analyses
• Support the development and implementation of the AAPS Quantitative X-ology/Pharmacology initiative
• Provide M&S scientists up-to-date information on relevant software solutions developed for population analyses

Want to Get Involved?
The Population PK/PD Focus Group is always in need of individuals interested in helping to plan future events. Please contact Dick Brundage if you are interested.

2004 Annual Meeting Poster/Podium Session: Maximizing the Impact of Population PK/PD Modeling and Simulation on Drug Development Decisions

• Population Pharmacokinetics for Assessing Drug-Drug Interactions: Considerations During Regulatory Review, John Duan, FDA (PDF)
• Designing a Biomarker Study for Compound LY1 based on Modeling and Simulation of Clinical Data from a Structurally Similar Compound LY2, Song Mu, Eli Lilly and Co. (PDF)
• A Population PK/PD Model Describes the Rapid, and Sustained Suppression of Urinary N-telopeptide Following Administration of AMG 162, a Fully Human Monoclonal Antibody Against RANKL, to Healthy Postmenopausal Women (PDF)

• NONMEM Software Bugs Overview, Luann Phillips, Cognigen Corp. (PDF)
• Regulatory Implications of Software Bugs, Joga Gobburu, FDA (PDF)
• NONMEM Non-influential ETA Bug and How to Fix It, Leonid Gibiansky, Metrum Research Group (PDF)

Presentations from the 2003 Is Population PK/PD Worth the Effort in Pediatric Drug Development roundtable in Salt Lake City:

• Intro & Questions - Gastonguay (PDF)
• Implementation Issues - Grasela (PDF)
• FDA Perspective - Lee (PDF)

• From Identifying & Maximizing the Value-Add to Considerations for Implementation - Fiedler-Kelly (PDF)

• Intro (PDF)
• Duffull (PDF)
• Gillespie (PDF)
• Ludden (PDF)
• Rosner (PDF)

JOIN THE POPULATION PK-PD FOCUS GROUP

To join the Population PK-PD Focus Group, click here.

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