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.
Introduction to FIH/Phase 1 Track
Application of Modeling & Simulation in Phase 1
Confidence in FIH PBPK models
PBPK modeling, with verification of predictive performance first performed in preclinical species, is superior to empirical methods for...
How We Build & Validate Industrial Strength Models
A strong, reliable tool tailored to the particular demands of the relevant endpoint that will get you...
Using a population mechanistic TMDD model calibrated on preclinical monkey data to simulate first-in-human
Which dose to choose to elicit the desired effect (efficacy), without causing harm (safety)?
Using a population PK/PD model developed on phase I to select the dose for Phase II: an example with an IgG1 mAb
Dosing of 30 mg/kg Q4W could guarantee >90% inhibition of membrane-bound receptor for 9 in 10 individuals