WebJan 21, 2024 · 对上述原料药的BCS分类汇总后发现,四个数据库中BCS分类一致的不到50%,且还有约20% ... 如舒必利 ,tsrlinc与BDDCS对中的分类分别为IV和III,此处有异议 … WebApr 12, 2016 · How lowsolubility currently defined aqueoussolubility drugsubstance highaccording HHS-FDA BCS criteria when: highestorally administered dose solubility(mg/ml) lessthan 250 ml metover pHrange 1-7.5 37CAccording HHS-FDA guidances, equilibriumsolubility should carriedout shake-flaskmethod (other methods like …
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【CDE老师文章】ICH基于BCS的生物等效性豁免最新技术要求
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