1st Edition
Statistical Design and Analysis in Pharmaceutical Science Validation, Process Controls, and Stability
580 Pages
by
CRC Press
580 Pages
by
CRC Press
580 Pages
by
CRC Press
Also available as eBook on:
"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."
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.
Biography
Chow, Shein-Chung; Liu, Jen-pei
