Statistical Design and Analysis in Pharmaceutical Science

Validation, Process Controls, and Stability

AvShein-Chung Chow,Jen-pei Liu

Häftad, Engelska, 2019

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Beskrivning

"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."

Produktinformation

Utgivningsdatum:2019-06-19
Mått:152 x 229 x 31 mm
Vikt:453 g
Format:Häftad
Språk:Engelska
Antal sidor:580
Förlag:Taylor & Francis Ltd
ISBN:9780367401870

Utforska kategorier

Matematisk statistik inom Naturvetenskap och teknik

Mer om författaren

Chow, Shein-Chung; Liu, Jen-pei

Recensioner i media

". . .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

Innehållsförteckning

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.