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"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."
The book contains black-and-white illustrations.
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.