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."

Sommario

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.

Info autore

Chow, Shein-Chung; Liu, Jen-pei

Dettagli sul prodotto

• Autori: Shein-Chung Chow, Shein-Chung (Duke Univ Chow, Shein-Chung (Duke Univ. School of Medicine) Chow, Shein-Chung Liu Chow, Jen-Pei Liu
• Con la collaborazione di: William R. Schucany (Editore della collana)
• Editore: Taylor & Francis Ltd.
• Lingue: Inglese
• Formato: Tascabile
• Pubblicazione: 31.08.2019
• EAN: 9780367401870
• ISBN: 978-0-367-40187-0
• Pagine: 580
• Categorie: Scienze naturali, medicina, informatica, tecnica > Matematica > Teoria delle probabilità, stocastica, statistica matematica; MATHEMATICS / Probability & Statistics / General, MEDICAL / Pharmacology, Probability & statistics, Probability and statistics