Buch, Englisch, 580 Seiten, Format (B × H): 159 mm x 234 mm, Gewicht: 1230 g
Validation, Process Controls, and Stability
Buch, Englisch, 580 Seiten, Format (B × H): 159 mm x 234 mm, Gewicht: 1230 g
Reihe: Statistics: A Series of Textbooks and Monographs
ISBN: 978-0-8247-9336-4
Verlag: Taylor & Francis Inc
"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
Undergraduate
Autoren/Hrsg.
Fachgebiete
- Mathematik | Informatik Mathematik Stochastik Wahrscheinlichkeitsrechnung
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
- Mathematik | Informatik Mathematik Stochastik Mathematische Statistik
- Technische Wissenschaften Technik Allgemein Mathematik für Ingenieure
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.