"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
". . .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. "
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.