University of Florida

The 3-Day Introductory Workshop in Population PK Data Analysis with NONMEM®

This three-day workshop has been designed to provide the necessary information to successfully implement population pharmacokinetic methodology in a drug development program and to provide the foundation for understanding the basics of NONMEM coding and interpretation of NONMEM output. The material is structured to impart both the theoretical and practical aspects of the population approach and is versatile so that participants with diverse backgrounds and areas of expertise may benefit. Examples of the use of population PK studies in drug development programs will be presented to provide specific details of various implementations and better illustrate essential aspects of population PK methods. Participants will gain an appreciation for the importance of accurate and sufficient data collection and learn how to proactively plan in order to maximize study effectiveness. Throughout the workshop, the presenters will provide examples from their experience to inform best practices for implementation and avoiding problems. Emphasis will be placed on compliance with the FDA’s Guidance for Industry on Population PK and the EMA’s Guideline on Reporting the Results of Population PK Analyses.

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The 3-Day Introductory Workshop in Population PK Data Analysis with NONMEM®

This three-day workshop has been designed to provide the necessary information to successfully implement population pharmacokinetic methodology in a drug development program and to provide the foundation for understanding the basics of NONMEM coding and interpretation of NONMEM output. The material is structured to impart both the theoretical and practical aspects of the population approach and is versatile so that participants with diverse backgrounds and areas of expertise may benefit. Examples of the use of population PK studies in drug development programs will be presented to provide specific details of various implementations and better illustrate essential aspects of population PK methods. Participants will gain an appreciation for the importance of accurate and sufficient data collection and learn how to proactively plan in order to maximize study effectiveness. Throughout the workshop, the presenters will provide examples from their experience to inform best practices for implementation and avoiding problems. Emphasis will be placed on compliance with the FDA’s Guidance for Industry on Population PK and the EMA’s Guideline on Reporting the Results of Population PK Analyses.

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The GastroPlus™ PBPK Modeling & Simulation Workshop: From Lead Optimization to Clinical Development

This three-day, hands-on course provides a working knowledge of the theories and application of our state-of-the-art PBPK modeling and simulation software to support internal research and regulatory interactions. A combination of presentations and interactive examples, taken from actual industry experience and using GastroPlus, illustrate how to recognize and deal with the multiple interacting phenomena that affect the absorption, pharmacokinetics, pharmacodynamics, and DDIs of drugs as they progress to the clinic. SOLD OUT!

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The GastroPlus™ PBPK Modeling and Simulation Workshop

This two-day, hands-on course will focus on the theories and application of our state-of-the-art PBPK modeling and simulation software for first-in-human (FIH) predictions in adults and extrapolation to pediatric populations, food effect predictions, and modeling & simulation of non-oral delivery pathways. A combination of presentations and interactive examples, taken from actual experience and using GastroPlus, illustrate how to recognize and deal with the multiple interacting phenomena which impact these activities.

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