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Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs复制

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D GUIDANCE
Center for Drug Evaluation and Research (CDER), 2022
pink.citeline.com
… information demonstrating that the 92 differences do not affect the safety or efficacy of the
proposed … 93 94 … or structural characteristics may be sensitive to the formulation design 146 and …

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