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Pharmacokinetic studies of neuromuscular blocking agents: Good clinical research practice (GCRP)

Lookup NU author(s): Dr Peter Wright

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Abstract

In September 1997, an international consensus conference on standardization of studies of neuromuscular blocking agents was held in Copenhagen, Denmark. Based on the conference, a set of guidelines for good clinical research practice (GCRP) in pharmacokinetic studies of neuromuscular blocking agents is presented. Guidelines include: design of the study; relevant patient groups to investigate; test drug administration, sampling and analysis; pharmacokinetic analysis; pharmacokinetic/pharmacodynamic modeling; population pharmacokinetics; statistics; and presentation of pharmacokinetic data. The guidelines are intended to aid those working in this research area; it is hoped that they will assist researchers, editors of scientific papers, and pharmaceutical companies in improving the quality of pharmacokinetic studies. (C) Acta Anaesthesiologica Scandinavica 44 (2000).

Publication metadata

Author(s): Viby-Mogensen J, Ostergaard D, Donati F, Fisher D, Hunter J, Kampmann JP, Kopman A, Proost JH, Rasmussen SN, Skovgaard LT, Varin F, Wright PMC

Publication type: Review

Publication status: Published

Journal: Acta Anaesthesiologica Scandinavica

Year: 2000

Volume: 44

Issue: 10

Pages: 1169-1190

ISSN (print): 0001-5172

ISSN (electronic): 1399-6576

URL: http://dx.doi.org/10.1034/j.1399-6576.2000.441002.x

DOI: 10.1034/j.1399-6576.2000.441002.x

PubMed id: 11065197

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