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Pharmacokinetic studies of neuromuscular blocking agents: Good Clinical Research Practice (GCRP)

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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.

Keywords: Good Clinical Research Practice (GCRP); neuromuscular blocking agents; pharmacokinetic/pharmacodynamic modeling; pharmacokinetics; population pharmacokinetics; statistics; study design

Document Type: Research Article

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

Affiliations: 1: Department of Anaesthesia and Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark 2: Department of Anaesthesia and Intensive Care, Herlev Hospital, Herlev, Denmark 3: Department of Anaesthesiology, CHUM-Hotel-Dieu de Montreal, University of Montreal, Montreal, Canada 4: Department of Anesthesiology and Perioperative Care, University of California, San Francisco, USA 5: University Department of Anaesthesia, University Clinical Department, Liverpool, UK 6: Department of Medicine I, Bispebjerg Hospital, Copenhagen, Denmark 7: Department of Anesthesiology, St. Vincent’s Hospital and Medical Center, New York, USA 8: Research Group for Experimental Anesthesiology and Clinical Pharmacology, University Hospital, Groningen, The Netherlands 9: Department of Pharmacology, The Royal Danish School of Pharmacy, Copenhagen, Denmark 10: Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark 11: Faculté de Pharmacie, University of Montreal, Montreal, Canada 12: Department of Anaesthesia, University of Newcastle, Newcastle-Upon-Tyne, UK

Publication date: November 1, 2000

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