De Braekeleer K, Fierens C, Corthout J
Service de Contrôle des Médicaments - Dienst Geneesmiddelen-onderzoek, rue Stévin, 137, B-1000 Bruxelles.
J Pharm Belg. 2006;61(4):111-6.
Fluconazole preparations formulated as capsules were evaluated with different tests, including in vitro dissolution and assay with previously validated methods according to the guideline of the European network of Official Medicines Control Laboratories (OMCLs). All examined products complied with our requirements and those described in the European and the US Pharmacopoeia and consequently they can be considered as pharmaceutically equivalent.
对制成胶囊剂型的氟康唑制剂进行了不同测试评估,包括体外溶出度测试以及根据欧洲官方药品控制实验室网络(OMCLs)指南采用先前验证过的方法进行含量测定。所有检验的产品均符合我们的要求以及欧洲和美国药典中所述要求,因此可被视为药学等效。