Quantitative Systems Pharmacology Modeling of Fibrotic Diseases
NAFLDsym Is Designed to Support Drug Development with Efficacy Predictions
The Future of Clinically Relevant Dissolution Testing and Physiologically Based Biopharmaceutics Modeling (PBBM/PBPK) in Drug Product Development, Manufacturing Changes and Controls
Regulatory applications of dissolution testing as per published FDA guidance...
AAPS Webinar: Translating manufacturing variants from in vitro to the clinic. Opportunities and gaps for IR formulations with additional IVIVC ‘Safe Space’ applications
Development of an in vitro/in vivo correlation (IVIVC) can be most challenging for immediate release (IR) products
2021 MIDD+ Welcome and Introduction
Evolving relationship between M&S and pharma R&D
Introduction to Phase III track with Beth Ludwig
Beth Ludwig, Associate Vice President, Quantitative Clinical Pharmacology, gives a brief introduction to the application of Modeling & Simulation in Phase 3 - questions to be addressed, speakers, and presentations.
Introduction to Phase II Track with Joel Owen
Joel Owen, Vice President of Pharmacometric Services, gives a brief introduction to the application of Modeling & Simulation in Phase 2 - questions to be addressed, speakers, and presentations.
Introduction to Post-Approval/Generics track with Ryan Franke
Ryan Franke, Director, Quantitative Clinical Pharmacology, gives a brief introduction to the application of Modeling & Simulation in the Post Approval/Generics phase - the value of modeling & simulation, speakers, and presentations.
Pharmacometrics in Phase 3 – Data Integration and Analysis to Support Dose and Labeling for the NDA
Phase 3 studeis typically involve 300 to 3,000 participants from patient populations for which the medicine is eventually intended to be used.
Optimizing sample size of a phase III trial with Simulx using a phase II popPD model
Goal: design of a bridging study
Panel Discussion: The Impact of Modeling in Drug Development
There is a rich, long-standing history of science and mathematical modeling that set the table for the current, rich MIDD environment
Keynote: Women in Pharmaceutical Science
Respect is a Simulations Plus Core Value
Pharmacometrics in Post Approval: Fulfillment of Requirements, Label Extension, and Life-Cycle Management
Aksana Jones, Associate Director, walks you through unleashing the full potential of model-informed drug development (MIDD) post-approval.
Pregnancy PBPK modeling, a necessary step towards safety and efficacy
Maxime LeMerdy, Senior Scientist discusses clinical trial and post-marketing information along with two case studies for Cefuroxime and Metronidazole.
Pharmacometrics Phase 2 Proof-Of-Concept Dose Selection Phase 3/Marketing
Sébastien Bihorel, Director, Pharmacometrics and Workflow Automation answers the question: "Where & how can pharmacometrics help?"