Statistical Design and Analysis in Pharmaceutical Science Validation, Process Controls, and Stability
Innbundet /
1995
/ Engelsk
Produktdetaljer
ISBN
9780824793364
Publisert
1995-02-22
Utgiver
Taylor & Francis Inc; CRC Press Inc
Vekt
1230 gr
Høyde
229 mm
Bredde
152 mm
Aldersnivå
UP, P, 05, 06
Språk
Product language
Engelsk
Format
Product format
Innbundet
Antall sider
580
Om bidragsyterne
Chow, Shein-Chung; Liu, Jen-pei". . .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. "
---Technometrics
"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."
Les mer
"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."
Les mer
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.
Les mer
Produktdetaljer
ISBN
9780824793364
Publisert
1995-02-22
Utgiver
Taylor & Francis Inc; CRC Press Inc
Vekt
1230 gr
Høyde
229 mm
Bredde
152 mm
Aldersnivå
UP, P, 05, 06
Språk
Product language
Engelsk
Format
Product format
Innbundet
Antall sider
580