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????????CPhI?????????2014

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2014?5?28??29?CHhI??????“??????2014”,???????????,????“????????(QbD)?????”?“????”????,??????????????,????????????,???????????,????????????????????(Blue Bell Consulting)???????????????????,???“????????(QbD)?????”?????

2014?5?28??29?CHhI??????“??????2014”,???????????,????“????????(QbD)?????”?“????”????,??????????????,????????????,???????????,????????????????????(Blue Bell Consulting)???????????????????,???“????????(QbD)?????”?????

?????,????“??????(QbD) - FDA??”?????,??????????????FDA?ICH?????,?????QbD????????????FDA/EMA????,?????2014?1??FDA??????????ANDA???????FDA?QbR????????????????????????????GMP????????????