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 Printable version |
Fabrication and control of a drug preparation in a clinical trial |
Journal de Pharmacie Clinique. Volume 18, Number 1, 78-80, Mars 1999, 4es ATELIERS DU SNPHPU
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 Résumé
Article gratuit
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Author(s) : F. PEYRON, E. IBRAHIM, V. AMIRAT-COMBRALIER, R. ELIAS, J.-J. CHARBIT, G. BALANSARD |
Summary : A prospective, randomised, double-blind clinical trial have been initiated in the Tropical diseases unit of F.-Houphouët-Boigny hospital in Marseilles to treat patients with paludism. As part of this trial, the pharmacy was asked to perform the preparation and control of quinine capsules 125 mg. The pharmacy also assumed the randomisation, the stock control and the dispensation of investigational products. Procedures for preparation and dispensation are presented and the high performance liquid chromatography method of dosage is described. The participation of hospital pharmacist in the preparation and the control of investigational products is becoming more and more frequent. This enhances his involvement in the quality control of clinical trials. |
Keywords : drug preparation, quinine, high performance liquid chromatography. |
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