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
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
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
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)
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
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
Pharmacometrics and Regulation
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
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
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
2021 MIDD+ Awards Presentation
Representation of Efavirenz-mediated Drug-Induced Liver Injury (DILI) Using Quantitative Systems Toxicology (QST)
Diane Longo, Senior Scientist, presents, "Representation of Efavirenz-mediated Drug-Induced Liver Injury (DILI) Using Quantitative Systems Toxicology (QST)"
How to Partner With Us
Scientific guidance based on subject knowledge
Application of the DILIsym® QST drug-induced liver injury model to evaluate the carcinogenic hazard potential of acetaminophen
Brett Howell, Divisional President, presents an overview of DILIsym® software, Acetaminophen risk assessment, and observations
Population Pharmacokinetic Evaluation and Missed-Dose Simulations for Eslicarbazepine Acetate Monotherapy in Patients with Partial-Onset Seizures
Luann Phillips, Distinguished Scientist of Pharmacometrics, discusses the issues, repercussions, and methods in her presentation titled, "Population Pharmacokinetic Evaluation and
Missed-Dose Simulations for Eslicarbazepine Acetate Monotherapy in Patients With Partial-Onset Seizures"
Exposure Response Modeling from the CLARITY Trail of Pimavanserin for Adjunctive Treatment of Major Depressive Disorder
In the CLARITY trial, a placebo-controlled, phase 2 trial of patients with major depressive disorder and inadequate reposnse to selective serotonin reuptake...
Closing Remarks
Evolving relationship between M&S and pharma R&D
Introduction Pre-Clinical M&S
Preclinical M&S Track
Introduction to ADMET Predictor®
ADMET Predictor Overview
Predicting optimal scheduling of drug combinations in lung cancer xenografts using a population PK/PD model
Bevacizumab-pemetrexed/cisplatin is a first-line therapeutic for advanced nonsquamous non-small cell lung cancer.