Thursday 16 October, 2025
PK-Sim(R) is a software tool for physiology-based pharmacokinetic whole-body modelling in laboratory animals (mouse, rat, dog) and humans. It is…
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Analyzing Event History Data with nlme in S
Thursday 16 October, 2025
PDF of presentation Pharmacokinetic (PK) and pharmacodynamic (PD) data are often collected in event history format, in which records representing…
Read moreModel-Based Drug Development: A FDA Critical Path Opportunity
Thursday 16 October, 2025
PDF of presentation The unprecedented growth over the past decade in public and private investment in biomedical science has yielded…
Read moreIntroduction to Categorical Data Analysis
Preclinical Population PK/PD of TGF beta RI Kinase inhibitor for Cancer
Thursday 16 October, 2025
Objectives: The primary objective of PK/PD modeling in preparation for the First Human Dose study was to estimate a pharmacologically…
Read moreChallenges in the Transition to Model-Based Development
Thursday 16 October, 2025
PDF of presentation The requirement to demonstrate the safety and effectiveness of new medicines coupled with the critical business challenge…
Read moreComplications in assessing the hepatic first-pass component of bioavailability
Thursday 16 October, 2025
Simcyp® has been a joint venture between the University of Sheffield and a consortium of the world’s major pharmaceutical companies…
Read moreEvaluation of a transit compartment model versus a lag time model for describing drug absorption delay
Thursday 16 October, 2025
PDF of presentation Background: Traditionally, a delay before the commencement of drug absorption has been modeled as a discrete lag…
Read moreStochastic Approximation EM algorithm in nonlinear mixed effects models: an evaluation by simulation
Thursday 16 October, 2025
PDF of presentation Context:: Maximum likelihood estimation in nonlinear mixed effects models cannot be directly performed as the likelihood has…
Read moreA physiologically based population pharmacokinetic model describing the non-linear disposition and blood distribution of indisulam in Caucasian and Japanese patients
Thursday 16 October, 2025
PDF of presentation Objectives: The pharmacokinetic profile of the investigational anti-cancer agent indisulam is nonlinear. This may partially be explained…
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