The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaivers[1] for other types of oral dosage forms based on pre-defined criteria may also be acceptable.
Physiologically Based Biopharmaceutics Modeling of Regional and Colon Absorption in Dogs
Colon absorption is a key determinant for the successful development of modified-release (MR) formulations, and the risk that colon absorption may limit the in vivo performance...
An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms
The requirements to waive in vivo bioequivalence studies for immediate release solid oraldosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaiversafor other types of oral dosage forms based on pre-defined criteria may also be acceptable.
Retrospective Analysis Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation Offers Improvements in Efficiency of the Design of Volunteer Infection Studies for Antimalarial Drug Development
Volunteer infection studies using the induced blood stage malaria (IBSM) model have been shown to facilitate antimalarial...
Simulations Plus Hosts the Inaugural 2021 MIDD+ Scientific Conference with over 50 Model-Informed Drug Development Sessions
Speakers from Academia, Large Pharma Collaborations and Regulatory Agencies shared their real-world impact using modeling & simulation technology
New Library of Tumor Growth Inhibition Models in Monolix
Presentation of the models in the TGI library available in Monolix and Simulx
Neutralization of European, South African, and United States SARS-CoV-2 mutants by a human antibody and antibody domains
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) transmission with several emerging variants remain uncontrolled in many countries, indicating the pandemic remains severe.
Leveraging Oral Drug Development to a Next Level: Impact of the IMI-Funded OrBiTo Project on Patient Healthcare
A thorough understanding of the behavior of drug formulations in the human gastrointestinal (GI) tract is essential when working in the field of oral drug development in a pharmaceutical company.
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?"
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