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ASEAN Guideline on Stability Study of Drug Products / Association of Southeast Asian Nations
Association of Southeast Asian Nations, 2018
42 tr.
Ký hiệu phân loại (DDC): 615.1
This guideline is intended to provide recommendations on the core stability study package required for drug products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the products being evaluated. This guideline can also be used to propose shelf- life based on the stability data generated from the study package.
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