Buch, Englisch, 580 Seiten, Format (B × H): 152 mm x 229 mm, Gewicht: 831 g
Validation, Process Controls, and Stability
Buch, Englisch, 580 Seiten, Format (B × H): 152 mm x 229 mm, Gewicht: 831 g
ISBN: 978-0-367-40187-0
Verlag: CRC Press
"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."
Zielgruppe
Professional Practice & Development
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
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.