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    藥品加速試驗室廠家研發試驗總指導原則

        想必,大家都了解藥品加速試驗室是用來對藥品失效評測所需長時間穩定的溫度、濕度環境和光照環境進行測量的儀器吧!今天就來簡單介紹下該設備關于新原料藥和新藥劑的ICH穩定性試驗總的指導原則!

        藥品加速試驗室新原料藥和新藥劑的ICH穩定性試驗指導原則是指出光照試驗時強力破壞試驗中的重要組成部分。新原料藥和新藥制劑應該經過適當的光穩定特征考察,證明其本身的光穩定性,即光照不能引起不可接受的變化。按照總指導原則中的“批號選擇”,光穩定性試驗只須選做一批樣品。在某些情況下如當這個產品發生變更或變化時(如處方。包裝),這些研究應再重復進行。
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