TextBook : Lyophilization of Pharmaceuticals and Biologicals, 1st Edition (PDF Download)

A Digital Textbook : Lyophilization of Pharmaceuticals and Biologicals, 1st Edition
By Kevin R. Ward, Paul Matejtschuk
ISBN 10: 1493989278 | ISBN 13:9781493989270
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1. Characterization of Formulations for Freeze Drying
2. Formulation and Process Development for Lyophilized Biological Reference Materials
3. Controlled Ice Nucleation Using ControLyo®Pressurization-Depressurization Method
4. Alternative Methods of Controlling Nucleation in Freeze Drying
5. Tunable Diode Laser Absorption Spectroscopy in Lyophilization
6. Containment Options for the Freeze-Drying of Biological Entities and Potent Materials
7. Freeze Drying Systems: Freeze Dryer Design Requirements & Automatic Loading and Unloading Systems (ALUS™)
8. Regulatory Aspects of Freeze Drying
9. Container and Reconstitution Systems for Lyophilized Drug Products
10. Scale-Up of Freeze-Drying Cycles, the Use of Process Analytical Technology (PAT) and Statistical Analysis
11. Through Vial Impedance Spectroscopy (TVIS): A Novel Approach to Process Understanding for Freeze-Drying Cycle Development
12. Lyophilization of High-Concentration Protein Formulations
13. Mechanical Behavior and Structure of Freeze Dried Cakes
14. High Resolution Mass Spectrometric Methods for Proteins in Lyophilized Solids


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