Chow, Shein-Chung; Liu, Jen-pei

". . .comprehensive. . ..a useful reference for practitioners as well as a good source for statisticians wishing to understand some of the key issues in these aspects of drug development. "---Publication of the International Statistical Institute". . .Particularly appealing in this book are the extensive explanations of technical concepts, beginning with a fine overview. . .and continuing as concepts such as assay validation, process validation, quality assurance, and stability studies are introduced subsequently. "---Technometrics

• Assay development; assay validation; scaleup design and analysis; USP tests and specifications; process validation; quality assurance; stability studies; accelerated testing; design for long-term stability studies; stability analysis with fixed batches; stability analysis with random batches. Appendices: statistical tables; SAS programs; regulations. references.