sin2008
第1楼2009/08/12
“稳定”一词,在药物剂型上,指的是单位剂量的化学和物理的完整性,以及在合适情况下,单位剂量对微生物污染的抵抗能力。
试试翻译,呵呵,多多指教。
summer0751
第5楼2009/08/14
谢谢楼上两位专家的解释,已经明白了。
还有几句话不理解,请指教一下。
1.Stability studies on active substances and packaged dosage forms are cinducted by means of "real-time","real-time"怎么理解呢?
2.Controlled room temperature limits the permissible excursions to those consistent with the maintenance of a mean kinetic temperature calculated to be not more than 25℃.
3.Accelerated studies also allow the interpretation of data and information on short-term spikes in storage conditions in addition to the excursions allowed by controlled room temperature.
summer0751
第9楼2009/08/17
这句话我看了好几遍,终于明白了。
我想是由于USP的通则中对controlled room temperature的可允许范围有明确的规定,而没有加速实验条件的偏差,所以这里才做特殊说明。