nurture 发表于 2025-3-28 17:54:22
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Vibrational Spectroscopic Methods for Quantitative Analysisg. This chapter reviews both quantitative and qualitative applications of spectroscopic analysis for pharmaceutical products. Several applications of these technologies to stability testing are discussed.植物茂盛 发表于 2025-3-29 07:56:40
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Post-approval Changes – Stability Requirements and Regulationswill be captured in a stability protocol and reviewed/approved by the team. Based on the submission strategy, a stability report will be written for inclusion in the supplement, variation (for global changes) and/or the annual report..In the US, the current regulations around changes are covered in