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

Autor: J, Viby-Mogensen, D, Ostergaard, F, Donati, D, Fisher, J, Hunter, J P, Kampmann, A, Kopman, J H, Proost, S N, Rasmussen, L T, Skovgaard, F, Varin, P M, Wright
Rok vydání: 2000
Předmět:
Zdroj: Acta anaesthesiologica Scandinavica. 44(10)
ISSN: 0001-5172
Popis: 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.
Databáze: OpenAIRE