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Quantifying Non-Standard Evidence for Drug Approval

Thursday 16 October, 2025

To approve a new drug for marketing, regulatory authorities generally require “substantial evidence” that it is effective relative to some…

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Constructing optimal designs for fitting pharmacokinetic models

Thursday 16 October, 2025

A brief review will be given of the available approaches to constructing optimal designs and an assessment of their usefulness…

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A Pharmacodynamic Markov Mixed Effect Model for Temazepams Effect on Sleep

Thursday 16 October, 2025

Background: In hypnograms, sleep is continuously monitored and sleep stage is routinely scored every 30 seconds. Direct analysis of such…

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Population PK/PD Of Craving Symptoms In An Enforced Smoking Cessation Population: Probabilistic And Indirect Modelling Approach.

Thursday 16 October, 2025

Objective: A placebo controlled, randomised, double blind, three periods, crossover trial was designed to investigate the relationship between craving scores…

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Validation Methods In Population Pharmacokinetics: A New Approach Based On Predictive Distributions With An Evaluation By Simulation

Thursday 16 October, 2025

We developed a validation approach based on predictive distributions for nonlinear mixed- -effects models. This validation method is to be…

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Optimal population designs for enoxaparin pharmacokinetics: evaluation by simulation

Thursday 16 October, 2025

We wished to optimise population pharmacokinetics designs under different constraints and to evaluate them by simulation for a new phase…

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In Search of an Optimal Furosemide Infusion Strategy in Children after Cardiac Surgery Using Modelling and Simulation

Thursday 16 October, 2025

Background Furosemide is frequently used in children to increase urinary output after cardiopulmonary bypass, but the optimal dosing strategy is…

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Population Pharmacokinetics in Paediatric Patients; the Good, the Bad and the Ugly

Thursday 16 October, 2025

Drug administration to paediatric patients presents a number of challenges due to their immature renal and hepatic function and differences…

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Pharmacokinetic/Pharmacodynamic Modeling of the Antipyretic Effect of Two Oral Formulations of Ibuprofen: Suspension and Effervescent Granules

Thursday 16 October, 2025

The population pharmacokinetic-pharmacodynamic relationships of racemic ibuprofen administered in suspension or effervescent granules were analyzed. Pharmacokinetics was studied in eighteen…

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The impact of patient compliance in pharmacokinetic/pharmacodynamic studies

Thursday 16 October, 2025

Population pharmacokinetics (PK) and pharmacodynamics (PD) study the variability between individuals in drug concentration and pharmacological effect when standard dosage…

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