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

Autor: 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.
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Zdroj: Acta Anaesthesiologica Scandinavica; Nov2000, Vol. 44 Issue 10, p1169-1190, 22p
Abstrakt: 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index