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](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
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](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
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](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
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](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
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](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
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](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
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](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
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](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
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?"
![Impact of MIDD During Phase II New Drug Development a Regulatory Perspective](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
Impact of MIDD During Phase II New Drug Development a Regulatory Perspective
Yaning Wang, Division of Pharmacometrics, Office of Clinical Pharmacology, OTS/CDER/OMTP/FDA discusses the impact of MIDD during Phase 2 of New Drug Development
![FDA’s Perspective on the Physiologically Based Pharmacokinetic (PBPK) Analyses for Biopharmaceutics Applications](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
FDA’s Perspective on the Physiologically Based Pharmacokinetic (PBPK) Analyses for Biopharmaceutics Applications
Banu Zolnik, from the Division of Biopharmaceutics/ONDP/OPQ/CDER/FDA, takes you through the FDA’s Perspective on PBPK Analyses for Biopharmaceutics Applications
![Quantitative Systems Toxicology Modeling Provides Novel Mechanistic Insights into Disease-related Tolvaptan Hepatotoxicity](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
Quantitative Systems Toxicology Modeling Provides Novel Mechanistic Insights into Disease-related Tolvaptan Hepatotoxicity
Paul B. Watkins, Howard Q Ferguson Distinguished Professor, Director, Institute for Drug Safety Sciences and James Beaudoin, Scientist I present Quantitative Systems Toxicology Modeling Provides Novel Mechanistic Insights into Disease-related Tolvaptan Hepatotoxicity.
![Using Model Informed Drug Development and Model Integrated Evidence to Support Generic Drug Development and Assessment](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
Using Model Informed Drug Development and Model Integrated Evidence to Support Generic Drug Development and Assessment
Liang Zhao, Division of Quantitative Methods & Modeling, Office of Research and Standards, Office of Generic Drugs, CDER, FDA presents on using model-informed drug development and model integrated evidence to support generic drug development and assessment
![Regulatory Perspectives for Reliable Model Informed Drug Development (MIDD)](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
Regulatory Perspectives for Reliable Model Informed Drug Development (MIDD)
Sarem Sarem, Biostat Unit, Office of Science Therapeutic Products Directorate, Health Canada, presents his thoughts on MIDD, Pharmacometrics, and Modeling & Simulation approaches in Phase III of drug development.
![Mathematical Modeling with NAFLDsym® Supports the Role of Adiponectin in the Reduction of Steatosis by the Anti FGFR1/KLB Bispecific Antibody](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
Mathematical Modeling with NAFLDsym® Supports the Role of Adiponectin in the Reduction of Steatosis by the Anti FGFR1/KLB Bispecific Antibody
Zack Kenz, Scientist II, discusses collaborative work done with Genentech and previously presented at the AASLD in 2019.
![The role of modeling and simulation in the approval of generic drug products](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
The role of modeling and simulation in the approval of generic drug products
Pharmacometrics and Regulation
![Efavirenz Physiologically Development and Validation as a Moderate CYP3A4 Inducer for Drug-Drug Interaction Predictions](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
Efavirenz Physiologically Development and Validation as a Moderate CYP3A4 Inducer for Drug-Drug Interaction Predictions
Efavirenz is an antiretroviral medication used to treat and prevent HIV/AIDS.
![Semi-Mechanistic PK/PD Model Effect Odanacatib, a Cathespin K Inhibtor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
Semi-Mechanistic PK/PD Model Effect Odanacatib, a Cathespin K Inhibtor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women
David Jaworowicz, Senior Director of Pharmacokinetics/Pharmacodynamics, presents objectives, study design, and data analysis for the semi-mechanistic PK/PD model of the effect of Odanacatib in Phase II studies of postmenopausal women
![Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia
Pharmacometrician, Hannah Huang, presents "Population Pharmacokinetic and Concentration-QTc Analysis of Quizartinib in Patients With FLT3-ITD–Positive Relapsed/Refractory Acute Myeloid Leukemia"
![2021 MIDD+ Awards](https://www.simulations-plus.com/wp-content/themes/simulations-plus/library/dist/img/default_square-large.jpg)
2021 MIDD+ Awards
2021 MIDD+ Awards Presentation