Statistical Design and Analysis of Stability Studies
ebook ∣ Chapman & Hall/CRC Biostatistics
By Shein-Chung Chow
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The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta
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