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Overview of model-building strategies in population PK/PD analyses: 2002–2004 literature survey

By C Dartois, K Brendel, E Comets, C M Laffont, C Laveille, B Tranchand, F Mentré, A Lemenuel-Diot and P Girard


What is already known about this subjectThe reviews already published on population pharmacokinetic/pharmacodynamic (PK/PD) analyses have focused on theory and have presented some clinical applications, evaluated validation practices in limited circumstances, defined the interest and sometimes the complexity of this approach in drug development or proposed a list of relevant articles.None of them has exhaustively evaluated published analyses and more precisely the model-building steps.In view of the statistical complexity of population PK/PD methodology, more attention is required to how models are built and how they are reported in the literature.What this study addsWith a strict methodology and by establishing a standardized tool, this survey provides an exhaustive, objective and up-to-date review of model-building practices.It reveals deficiencies in information reporting in most articles and the genuine need for guidance in publishing.An initial, minimal list of items is suggested, which can be used by authors and reviewers in pharmacology journals.The value of published peer-reviewed papers could be greatly improved if authors were to address the suggested list of items systematically

Topics: Pharmacokinetics and Pharmacodynamics
Publisher: Blackwell Science Inc
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Provided by: PubMed Central
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