What are the filing requirements for ANDA-USA, Europe,
Brazil, South Africa, Japan and Emerging Markets
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Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.
0 Answers Alchem, Getz Pharma Research, Hovid Berhad,
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What are the filing requirements for ANDA-USA, Europe, Brazil, South Africa, Japan and Emerging Markets
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