Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability

ISBN-13: 9780367401870 / Angielski / Miękka / 2019 / 580 str.

Shein-Chung Chow; Jen-Pei Liu

Opis

"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."

Recenzje

". . .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

Spis treści

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.

O autorze

Chow, Shein-Chung; Liu, Jen-pei