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.
Purpose: To apply formal optimal experimental design methodology to the design of a clinical trial where the pharmacodynamic response is…
Read morePopulation Pharmacokinetics and Pharmacodynamics of Zidovudine HIV Infected Infants and Children
Clinical studies suggest infants experience increased toxicity from Zidovudine (ZDV) compared to older children. To assess whether this difference could…
Read moreA Population Pharmacokinetic Analysis Of A New Antibody Chemotherapeutic Agent: Gemtuzumab Ozogamicin.
Gemtuzumab ozogamicin (GO) is a novel antibody-chemotherapeutic conjugate consisting of an engineered human anti-CD33 antibody (hP67.6) linked to a potent…
Read moreAn Interactive Multiple Model (Imm) Estimation Approach To Updating Posteriors In Pharmocokinetic Models Having Changing Parameter Values
This report considers updating Bayesian posterior densities for pharmacokinetic models having changing parameter values. The prior probability is assumed to…
Read moreA Strategy For Selection Of Dose Sizes And Dosing Algorithm Based On A Real Data Example
In clinical drug development, dosing based on covariates needs to be considered and if necessary, a dosing algorithm has to…
Read morePopulation Pharmacokinetics Of Nelfinavir In HIV-1-Infected Children
Objective: The population pharmacokinetics (PK) of nelfinavir were assessed in human immunodeficiency virus type 1 (HIV-1)-infected children receiving nelfinavir 30…
Read morePopulation pharmacokinetics of the novel marine derived anti-cancer agent Ecteinascidin 743 in a phase I study using non-linear mixed effects modelling.
Ecteinascidin 743 (ET-743) is a novel anti-cancer agent isolated from the Caribbean tunicate Ecteinascidia turbinata. A phase I clinical trial…
Read moreUse of Phase I PK/PD results in design and analysis of Clinical trials with Sparse data
In cardiovascular drug development it is important to acquire good insight into PK/PD relationships in healthy volunteers before proceeding to…
Read moreApplication of population approach to TDM services and educational programs
Introduction: Division of TDM has been established from April 1996 and located in Kitasato Institute Hospital from May 1999. We…
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