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

"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."

List 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.

About the author

Chow, Shein-Chung; Liu, Jen-pei

Product details

• Authors: Shein-Chung Chow, Shein-Chung (Duke Univ Chow, Shein-Chung (Duke Univ. School of Medicine) Chow, Shein-Chung Liu Chow, Jen-pei Liu
• Assisted by: William R. Schucany (Editor of the series)
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Paperback / Softback
• Released: 31.08.2019
• EAN: 9780367401870
• ISBN: 978-0-367-40187-0
• No. of pages: 580
• Subjects: Natural sciences, medicine, IT, technology > Mathematics > Probability theory, stochastic theory, mathematical statistics; MATHEMATICS / Probability & Statistics / General, MEDICAL / Pharmacology, Probability & statistics, Probability and statistics