Objective: The objective of the work presented here is to optimize the design and analysis of a Phase II proof-of-concept…
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Population pharmacokinetics/-dynamics of dabigatran, the active form of the new oral direct thrombin inhibitor dabigatran etexilate (BIBR 1048) in patients undergoing hip replacement
Introduction: The oral direct thrombin inhibitor prodrug dabigatran etexilate is under development for the prevention of thrombosis in patients at…
Read morePatient adherence and the evolution of resistance to anti-viral agents
The paper will discuss recent work on the interplay between patient adherence and the evolution of drug resistance in HIV-1…
Read moreEvaluation of a Random Sparse Sampling Design: An Assessment of Power and Bias Using Simulation
Objectives: Assess power and sample size requirements for a population pharmacokinetic (PK) substudy of a phase III clinical trial using…
Read moreDesign and power PK/PD experiments using very sparse data
Objectives: The design of PK/PD experiments is a critical issue for improving the efficiency of pharmacology trials. An optimal design…
Read moreUsing SAS for non-linear mixed modelling – An overview
PDF of presentation The NLMIXED procedure in SAS fits nonlinear mixed models, that is, models in which both fixed and…
Read moreAn Application of Modelling and Simulation to Type 2 Diabetes: Development of a general drug-disease model based on a meta analysis of over 40 studies investigating 5 PPAR drugs
PDF of presentation The PPARγ / PPARαγ class of drugs represent an excellent addition to the pharmacotherapeutic choices for the…
Read moreDisease progression modelling; application of population analysis to distinguish between symptomatic and protective treatment effects.
Background: For certain diseases, drug treatment effects can only be evaluated relative to the disease progression over time. Model analysis…
Read moreComparison of the pharmacokinetics of S-1, an oral anticancer agent, in Western and Japanese patients
Objective: S-1 is an oral anticancer agent combining tegafur (FT), a prodrug of 5-fluorouracil (5-FU), with potassium oxonate (oteracil) and…
Read morePopulation Pharmacokinetic Modelling of a Subcutaneous Depot for GnRH Antagonist Degarelix
Objectives: The objective of the present analysis is to develop a population pharmacokinetic model that describes the spontaneous subcutaneous (SC)…
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