Statistical design and analysis in pharmaceutical science : validation, process controls, and stability
著者
書誌事項
Statistical design and analysis in pharmaceutical science : validation, process controls, and stability
（Statistics : textbooks and monographs, v. 143）
M. Dekker, c1995
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注記
Bibliography: p. 549-555
Includes index
内容説明・目次
内容説明
"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."
目次
- 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.
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