Workshops

Join us for hands-on PBPK modeling, Quantitative Systems Pharmacology (QSP), and population PK/PD data analyses training near you. Space is limited, so register soon!

Workshops in Mumbai, India

The GastroPlus™ Pharmaceutical Development Workshop
Sep 27-28, 2018

Mumbai, India

The GastroPlus™ Pharmaceutical Development Workshop

This two-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, BABE and helpful for generic drug industry. Register by following instructions on the brochure.

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Workshops in San Diego, California

Using DILIsym to Assess the Liver Safety of Drugs and Drug Candidates
Oct 6, 2018

San Diego, CA

Using DILIsym to Assess the Liver Safety of Drugs and Drug Candidates

FREE! This 1 day hands‐on workshop provides a working knowledge of the basic theories and application of state‐of‐the‐art quantitative system toxicology (QST) modeling and simulation software (DILIsym) for the analysis of the potential for drugs and drug candidates to cause drug‐induced liver injury (DILI), or for the investigation of mechanisms involved in a documented DILI event. A combination of presentations and interactive examples using DILIsym will illustrate how to gather the appropriate in vitro toxicity data, derive DILIsym related toxicity parameters, conduct simulations of expected outcomes and analyze results for impacting decisions. This is a beginner’s course ‐prior experience with DILIsym is not required.
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Extending MAM/PBPK modeling approaches to predict non‐oral delivery of drugs 
Oct 12, 2018

San Diego, California

Extending MAM/PBPK modeling approaches to predict non‐oral delivery of drugs 

FREE! The focus of this 1‐day workshop will be to discuss development of MAM/PBPK models for major non oral administration routes (nasal/pulmonary, dermal, ocular, and oral cavity) and how they can be applied to address key development questions. A combination of presentations and interactive examples using the GastroPlus™ PBPK modeling platform will illustrate how to parameterize baseline models and, once validated, how they can be deployed to predict FIH exposure and simulate the impact of formulation changes on local and systemic exposure to identify clinically relevant specifications.

Please note - this FREE workshop is open to anyone – registration to the ACoP conference is not required. You will need to register your attendance to the workshop below.
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Workshops in Orlando, Florida

University of Florida

The GastroPlus™ PBPK Modeling & Simulation Workshop: From Lead Optimization to Clinical Development
Oct 15-17, 2018

University of Florida, Orlando, FL

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.

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The 3-Day Introductory Workshop in Population PK Data Analysis with NONMEM®
Nov 13-15, 2018

University of Florida, Orlando, FL

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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