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Eudralex Volume 9: The European Medicines Agency (EMA ) recently published GVP () Module V (Revi
ICH Q1E 稳定性数据评价,附录B,B.3.2 Testing for poolability ,B.3.2.。请问batch factor和 non-batch factor分别指什么???请大
ICH) is planning to take up two new topics,'s meeting in Montreal in May and June.'s 1997 E8
§ 211.180., for certain over-the-counter (OTC) drugs,(§ 211.180(a)).(§ 211.180(c)),(§ 211.180(d))