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In the pharmaceutical industry, labeled shelf-life on the immediate container of a drug product provides the consumer the confidence that the drug product will retain its identity, strength, quality, and purity throughout the expiration period of the drug product. Drug shelf-life is usually supported by stability data collected from stability studies conducted under appropriate storage conditions. The FDA has the authority to issue recalls for drug products due to a problem occurring in the manufacture or distribution of the product that may present a significant risk to public health. As indicated in the FDA Report to the Nation in 2004, stability data not supporting expiration the date is among the top three reasons for drug recalls in the fiscal year of 2004, during which 215 prescription drug products and 71 over-the-counter drug products were recalled. The cost for a recall and possible penalty could be a disaster for the pharmaceutical company. Thus, stability studies play an important role in drug safety and quality assurance.
The purpose of this book is to provide a comprehensive and unified presentation of the principles and methodologies of design and analysis of stability studies. In addition, this book is intended to give a well-balanced summary of current regulatory perspectives and recently developed statistical methods in the area. It is our goal to provide a complete, comprehensive and updated reference and textbook in the area of stability design and analysis in pharmaceutical research and development.
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