Buch, Englisch, 452 Seiten, Format (B × H): 286 mm x 221 mm, Gewicht: 1346 g
Buch, Englisch, 452 Seiten, Format (B × H): 286 mm x 221 mm, Gewicht: 1346 g
ISBN: 978-1-138-10383-2
Verlag: Taylor and Francis
Features:
Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions
Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing
Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements
Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
Part I Regulatory and Manufacturing
Chapter 1. Sterile Manufacturing Formulations Template
Chapter 2. Inspection of Sterile Product Manufacturing Facilities
Chapter 3. New Drug Application for Sterilized Products
Chapter 4. Validation of Cleaning Process
Chapter 5. Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Chapter 6. Analysis of the Expression Construct in Cells Used for Production of rDNA-Derived Protein Products
Chapter 7. Stability Testing of Biotechnological/Biological Products
Chapter 8. Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
Chapter 9. Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
Chapter 10. Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Chapter 11. Essential Clean-Room Design Elements
PartII Manufacturing Formulations
Sterile Product Formulations
Part III Commercial Pharmaceutical Formulations
Commercial Pharmaceutical Formulations
Index