Conventional biostatistical analysis of clinical efficacy trials is based on end-points and ignors the longitudinal nature and hierarchical structure of…
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Population Disease Progress Models for the Time Course of HAMD Score in Depressed Patients Receiving Placebo in Anti-Depressant Clinical Trials
Introduction: The time course of depression in humans is well known to be cyclical with episodes of depression and typically…
Read moreDisease Progression in Parkinson’s Disease – Evidence for Protective Effects of Drug Treatment
PDF of presentation Objectives: The effects of drug treatment on the progression of Parkinson’s disease have been studied in large…
Read moreSimulations using a mechanistic DDI model: individual risk assessment.
S 16257 is a selective heart rate reducing agent which is developed for the treatment of stable angina pectoris. It is…
Read moreDesign and practical problems in population PK studies in the elderly
Ageing is a highly complex and variable process, and old people do not age in a uniform way. Several parameters…
Read moreAssessing the robustness of competing dose regimens to incomplete compliance
In drug development, non-compliance to the prescribed regimen is the Cinderella of pharmacotherapy. However, instead of being an ignored beauty,…
Read moreAn approach to formal decision making in exploratory development
Zipped PDF of presentation Decision making is an everyday activity in pharmaceutical research and development. Sometimes decision making is formalized…
Read moreOptimising Design In Paediatric Regulatory Studies
Most societies define children population by age group and/or by sexual activity. However, these definitions do not support current PKPD…
Read moreA preliminary Report On The Pharmacokinetics Of Tirapazamine
Eight males and four females, aged 38-61 years, were treated with the novel hypoxic cell cytotoxic agent, tirapazamine, in a…
Read moreIndapamide Population Phamacokinetics Via Mixed Effects Modeling: Models Building And Bayesian Estimation Of Pharmacokinetics Parameters.
Indapamide is a very effective and safe sulphonamide diuretic, on the market at the dose of 2.5mg, for the treatment…
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