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