Statistical design and analysis in pharmaceutical science : validation, process controls, and stability
Author(s)
Bibliographic Information
Statistical design and analysis in pharmaceutical science : validation, process controls, and stability
（Statistics : textbooks and monographs, v. 143）
M. Dekker, c1995
Available at / 13 libraries
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Research Institute for Economics & Business Administration (RIEB) Library , Kobe University図書
615-13s081000090083*
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University of Toyama Library, Medical and Pharmaceutical Library図
: acid-freeQV771//C552sT9500006641*
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Note
Bibliography: p. 549-555
Includes index
Description and Table of Contents
Description
"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."
Table of Contents
- 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.
by "Nielsen BookData"