Drug development decision making is greatly facilitated by having a model of the likely clinical profile of the new investigational…
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Modelling and simulation of the incidence of adverse events in clinical trials.
PDF of presentation Objectives: Predict the incidence of a pre-defined adverse event in dose ranging trials of a new compound….
Read moreTransformations and Variance Functions in Nonlinear Mixed-Effects Models
Population pharmacokinetics (PK) studies consist of longitudinal concentration measurements in a sample of individuals, with the concentration profiles typically being…
Read moreAssessment of the in vivo relative potency of the hydroxylated metabolite of darifenacin for the reduction of salivary flow using a population pharmacokinetic-pharmacodynamic meta-analysis
Objectives: To estimate the in vivo potency of the hydroxylated metabolite (UK-148,993) to reduce salivary flow (SF) relative to that…
Read moreA Unified Parametric/Nonparametric Approach to PK/PD Population Modeling
Currently the most popular computational methods for PK/PD population modeling are based on a parametric maximum likelihood (ML) approach that…
Read moreAccurate Maximum Likelihood Estimation for Parametric Population Analysis
PDF of presentation Objectives: The statistical performance of estimators of fixed and random effects in parametric population PK analyses can…
Read moreExtrapolation of pharmacokinetics and toxicity from pre-clinical data to humans
Extrapolation of data from animal studies is required to predict pharmacokinetics and/or toxicity in humans during the development of new…
Read moreDevelopment of a PBPK model for drug-drug interaction of orally delivered drugs using in-vitro data
Early screening systems, like in-vitro preparations of human microsomes can give an indication whether or not a pharmacokinetic interaction between…
Read morePopulation Modelling of the Absolute Bioavailability and Pharmacokinetics of Phenobarbitone in Infants with Seizures
PDF of presentation Objectives: Seizures occur in 1-2 infants per 1000 term live births and constitute a medical emergency with…
Read moreEstimate the time varying brain receptor occupancy in PET imaging
Positron-Emission Tomography (PET) is an imaging technology currently used in drug development as a non-invasive measure of drug distribution and…
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