Shein-Chung Chow, Jen-Pei Liu

Statistical Design and Analysis in Pharmaceutical Science (eBook, ePUB)

Validation, Process Controls, and Stability

• Format: ePub

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."

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 580
• Erscheinungstermin: 3. Oktober 2018
• Englisch
• ISBN-13: 9781351990745
• Artikelnr.: 73200820

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.