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Optimal Design for Categorical Data

Thursday 16 October, 2025

The design of pharmacokinetic studies using a range of optimality criteria has been described in the pharmacokinetic and statistical literature….

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Application Of Optimal Design For Categorical Pharmacodynamic Measures In Clinical Trials.

Thursday 16 October, 2025

Purpose: To apply formal optimal experimental design methodology to the design of a clinical trial where the pharmacodynamic response is…

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Population Pharmacokinetics and Pharmacodynamics of Zidovudine HIV Infected Infants and Children

Thursday 16 October, 2025

Clinical studies suggest infants experience increased toxicity from Zidovudine (ZDV) compared to older children. To assess whether this difference could…

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A Population Pharmacokinetic Analysis Of A New Antibody Chemotherapeutic Agent: Gemtuzumab Ozogamicin.

Thursday 16 October, 2025

Gemtuzumab ozogamicin (GO) is a novel antibody-chemotherapeutic conjugate consisting of an engineered human anti-CD33 antibody (hP67.6) linked to a potent…

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An Interactive Multiple Model (Imm) Estimation Approach To Updating Posteriors In Pharmocokinetic Models Having Changing Parameter Values

Thursday 16 October, 2025

This report considers updating Bayesian posterior densities for pharmacokinetic models having changing parameter values. The prior probability is assumed to…

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A Strategy For Selection Of Dose Sizes And Dosing Algorithm Based On A Real Data Example

Thursday 16 October, 2025

In clinical drug development, dosing based on covariates needs to be considered and if necessary, a dosing algorithm has to…

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Population Pharmacokinetics Of Nelfinavir In HIV-1-Infected Children

Thursday 16 October, 2025

Objective: The population pharmacokinetics (PK) of nelfinavir were assessed in human immunodeficiency virus type 1 (HIV-1)-infected children receiving nelfinavir 30…

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Population pharmacokinetics of the novel marine derived anti-cancer agent Ecteinascidin 743 in a phase I study using non-linear mixed effects modelling.

Thursday 16 October, 2025

Ecteinascidin 743 (ET-743) is a novel anti-cancer agent isolated from the Caribbean tunicate Ecteinascidia turbinata. A phase I clinical trial…

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Use of Phase I PK/PD results in design and analysis of Clinical trials with Sparse data

Thursday 16 October, 2025

In cardiovascular drug development it is important to acquire good insight into PK/PD relationships in healthy volunteers before proceeding to…

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Application of population approach to TDM services and educational programs

Thursday 16 October, 2025

Introduction: Division of TDM has been established from April 1996 and located in Kitasato Institute Hospital from May 1999. We…

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