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Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.\u003cbr\u003e\u003c\/p\u003e\u003cp\u003ePart Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. \u003cbr\u003e\u003c\/p\u003e\u003cp\u003ePart Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. 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