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!

Mainz, Germany

September 23-27, 2019

Registration CLOSED!


University of Florida, Orlando, Florida

University of Florida

The 3-Day Introductory Workshop in Population PK Data Analysis with NONMEM®
Oct 17-19, 2019

Orlando, 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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Orlando, Florida

Applying MAM/PBPK Modeling to Predict Positive/Negative Food Effects: Approaches and Special Considerations
Oct 19, 2019

Orlando, Florida

Applying MAM/PBPK Modeling to Predict Positive/Negative Food Effects: Approaches and Special Considerations

Sorry, this workshop is FULL.

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Optimization of Exposure, Safety, and Efficacy through Modeling and Simulation: a Simulations Plus workshop on machine learning + PBPK (GastroPlus), PKPD modeling (KIWI), QSP (NAFLDsym), and QST (DILIsym)
Oct 20, 2019

Orlando, Florida

Optimization of Exposure, Safety, and Efficacy through Modeling and Simulation: a Simulations Plus workshop on machine learning + PBPK (GastroPlus), PKPD modeling (KIWI), QSP (NAFLDsym), and QST (DILIsym)

Modeling and simulation (M&S) is now a critical activity within the drug development process. The Simulations Plus family of companies has a wide range of experience and tools available to enable effective M&S. This workshop will provide a background knowledge of multiple M&S approaches and describe how Simulations Plus has partnered with developers to help facilitate better decisions and smarter investments. This workshop will provide an excellent foundation for those looking to learn more about various types of M&S approaches, as well as those looking for implementable solutions. This workshop is FREE for all attendees.

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Tokyo, Japan

GastroPlus® Introductory Workshop
Sep 30, 2019-Oct 2, 2019

Tokyo, Japan

GastroPlus® Introductory Workshop

The Introductory Workshop is a hands-on, practical three-day training course that provides deep learning of the basic theory and application of GastroPlus ® . The objective is to acquire the basic theory, modeling and simulation required for GastroPlus® . Because it is a beginner course, deep knowledge and experience of GastroPlus ® are not required. In Introductory Workshop , you will learn the following: Understand the interactions that exist in various mechanistic phenomena affecting drug absorption, pharmacokinetics (compartments PK, PBPK), and pharmacodynamics. Predict drug properties from chemical structure using ADMET Predictor ™ module, Evaluation of PBPK model and compartment model, Prediction of human first-dose study dose from preclinical and in vitro data, Evaluation of formulation strategies such as micronization and nano-fabrication, Fitting nonlinear metabolic and transport models, Tracking parent and metabolite concentrations in plasma and tissues, Optimization method, objective function weighting, binding conditions, Construction of PBPK / PD model, Population simulation, IVIVC analysis, Metabolic and transporter-based drug-drug interactions, Biologic PBPK modeling

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GastroPlus® Advanced Training Workshop
Oct 3-4, 2019

Tokyo, Japan

GastroPlus® Advanced Training Workshop

Advanced training is broken into two expert courses to get the most out of GastroPlus® at a practical level. A case study from a US pharmaceutical company is conducted as a case study. This is especially recommended for those who have participated in the above GastroPlus® Introductory Workshop. Learn how to use modeling and simulation for complex phenomena that affect each other such as absorption, PBPK / PD, DDI, administration route, and dosage form. Understand drug absorption (passive transport / carrier transport), metabolism and distribution processes in the small intestine and other tissues, pharmacokinetics (compartments PK, PBPK), and mechanistic interactions that affect pharmacodynamics. You will learn how to properly use modeling and simulation in formulation evaluation and formulation design that examines dissolution, absorption, pharmacokinetics, administration route, and dosage form. Understand the mechanistic interactions affecting small intestinal transit, absorption (passive transport / carrier transport), first pass metabolism and PK and the effects of these phenomena on the drug product.

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