缓释制剂体内研究有关问题的思考

Consideration of in vivo studies of extended release dosage forms

文中对缓释制剂体内研究涉及的有关问题进行了分析讨论,重点讨论了缓释制剂的生物利用度及生物等效性研究的基本要求、多规格缓释制剂体内研究的考虑、缓释制剂临床试验的基本研究思路,强调了食物对生物利用度影响研究及餐后生物等效性试验在缓释制剂体内研究中的重要性,并对体内研究与药学研究的关系以及如何结合体内外研究结果开展进一步工作进行了阐述。

Problems concerning in vivo studies of extended release dosage forms were discussed in this article. The discussion focused on general considerations of bioavailability and bioequivalence study, considerations of in vivo studies of multiple strengths, and general considerations of clinic trials of extended release dosage forms. The importance of food effect on bioavailability and post-meal bioequivalence in studies of extended release dosage forms were emphasized. The discussion also dealt with the relation between pharmaceutical studies and in vivo studies, as well as further studies based on in vivo and in vivo results.