生物等效性
体内
药理学
药品
阿昔洛韦
体外
剂型
活性成分
化学
药代动力学
医学
免疫学
生物技术
生物
生物化学
人类免疫缺陷病毒(HIV)
疱疹病毒科
病毒性疾病
作者
Katrin Tiffner,Isadore Kanfer,Thomas Augustin,Reingard Raml,Sam G. Raney,Frank Sinner
标识
DOI:10.1016/j.ijpharm.2021.121186
摘要
The aim was to evaluate whether an in vitro release test (IVRT) could differentiate the release rates from five pharmaceutically equivalent acyclovir cream products and one ointment compared to that from a reference product, Zovirax cream (USA), to identify a test product with an inequivalent drug release rate that could serve as negative control for bioequivalence (BE) in a separate in vivo study. The reference product showed equivalent drug release rates compared to itself. The six test products failed to show equivalent drug release rates compared to the reference product. Aciclovir 1A pharma cream was selected to serve as a negative control for subsequent BE studies, since it exhibited the greatest difference in release rate among all creams, compared to the reference product. The results of this study indicate that IVRT results can be highly sensitive and may discriminate clinically relevant differences between products. Results from an appropriately validated IVRT method can support a demonstration of BE by showing that the drug release rates from test and reference products are statistically equivalent, mitigating the risk that differences may exist between the products which may influence in vivo performance of the drug product.
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