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Expiration labels provide consumers with the confidence that drug products will retain their identity, strength, quality, and purity throughout the expiration period. Statistical Design and Analysis of Stability Studies illustrates a comprehensive and unified presentation of the principles and methodologies in the design and analysis of stability studies. In addition, the book presents a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. It serves as a complete, updated reference and textbook in the area of stability design and analysis in pharmaceutical research and development.