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

• Published in: Acta anaesthesiologica Scandinavica Vol. 44; no. 10; pp. 1169 - 1190
• Main Authors: Viby-Mogensen, J., Østergaard, D., Donati, F., Fisher, D., Hunter, J., Kampmann, J. P., Kopman, A., Proost, J. H., Rasmussen, S. N., Skovgaard, L. T., Varin, F., Wright, P. M. C.
• Format: Journal Article
• Language: English
• Published: Copenhagen Munksgaard International Publishers 01.11.2000; Blackwell
• Subjects: Anesthetics. Neuromuscular blocking agents; Biological and medical sciences; Body Temperature; Calibration; Critical Illness; Good Clinical Research Practice (GCRP); Humans; Medical sciences; Models, Biological; neuromuscular blocking agents; Neuromuscular Blocking Agents - pharmacokinetics; Neuropharmacology; pharmacokinetic/pharmacodynamic modeling; pharmacokinetics; Pharmacology. Drug treatments; population pharmacokinetics; statistics; study design; Neuromuscular blocking agent; Human; Pharmacokinetic pharmacodynamic relationship; Statistical analysis; Methodology; Clinical trial; Models; Pharmacokinetics; Recommendation
• ISSN: 0001-5172; 1399-6576
• DOI: 10.1034/j.1399-6576.2000.441002.x

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.