Shein-Chung Chow, Jen-Pei Liu

Statistical Design and Analysis in Pharmaceutical Science

Validation, Process Controls, and Stability

• Broschiertes Buch

Produktbeschreibung

"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."

Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• Seitenzahl: 580
• Erscheinungstermin: 19. Juni 2019
• Englisch
• Abmessung: 234mm x 155mm x 33mm
• Gewicht: 771g
• ISBN-13: 9780367401870
• ISBN-10: 0367401878
• Artikelnr.: 57785272

Autorenporträt

Chow, Shein-Chung; Liu, Jen-pei

Inhaltsangabe

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.