Titlebook: Handbook of Stability Testing in Pharmaceutical Development; Regulations, Methodo Kim Huynh-Ba Book 2009 Springer-Verlag New York 2009 Deve

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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.

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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

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