title: Pharmacokinetic studies of neuromuscular blocking agents: good clinical research practice (GCRP).
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.
authors.affiliation: Department of Anaesthesia and Intensive Care, Copenhagen University Hospital, Rigshospitalet, Denmark. viby@rh.dk
authors.forename: J
authors.initials: J
authors.lastname: Viby-Mogensen
authors.forename: D
authors.initials: D
authors.lastname: Ostergaard
authors.forename: F
authors.initials: F
authors.lastname: Donati
authors.forename: D
authors.initials: D
authors.lastname: Fisher
authors.forename: J
authors.initials: J
authors.lastname: Hunter
authors.forename: J P
authors.initials: JP
authors.lastname: Kampmann
authors.forename: A
authors.initials: A
authors.lastname: Kopman
authors.forename: J H
authors.initials: JH
authors.lastname: Proost
authors.forename: S N
authors.initials: SN
authors.lastname: Rasmussen
authors.forename: L T
authors.initials: LT
authors.lastname: Skovgaard
authors.forename: F
authors.initials: F
authors.lastname: Varin
authors.forename: P M
authors.initials: PM
authors.lastname: Wright
mesh_terms: D001831:Body Temperature; D002138:Calibration; D016638:Critical Illness; D006801:Humans; D008954:Models, Biological; D009466:Neuromuscular Blocking Agents / Q000493:pharmacokinetics*
chemical_list: D009466:Neuromuscular Blocking Agents