TY  - BOOK
AU  - Rey,Louis
AU  - May,Joan C.
TI  - Freeze-drying/lyophilization of pharmaceutical and biological products
T2  - Drugs and the pharmaceutical sciences
SN  - 0824748689
U1  - 615.19 22
PY  - 2004///]
CY  - New York
PB  - Marcel Dekker
KW  - Freeze-drying
KW  - Drugs
KW  - Drying
KW  - Biological products
N1  - Foreword --
Preface --
Contents --
Chapter 1: Glimpses into the Realm of Freeze-Drying: Fundamental Issues --
Chapter 2: Structural and Dynamic Properties of Bulk and Confined Water --
Chapter 3: Mechanisms of Protein Stabalization During Freeze-Drying and Storage: The Relative Importance of Thermodynamic Stabalization and Glassy State Relaxation Dynamics --
Chapter 4: Freezing and Annealing Phenomena in Lyophilization --
Chapter 5: Freezing- and Drying-Induced Pertubations of Protien Structure and Mechanisms of Protein Protection by Stabilizing Additives --
Chapter 6: Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation, and it's Effect on Storage Stability --
Chapter 7: Formulation Characterization --
Chapter 8: Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Non-Aqueous Co-Solvent Systems --
Chapter 9: Cosure and Container Considerations in Lyophilization --
Chapter 10: Advanced Glassware for Freeze-Drying --
Chapter 11: Critical Steps in the Preperation of Elastomeric Closures for Biopharmaceutical Freeze-Dried Products --
Chapter 12: Development of a New Concept for Bulk Freeze-Drying: LYOGUARD Freeze-Dry Packaging --
Chapter 13: Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture --
Chapter 14: Freeze-Drying of Biological Standards --
Chapter 15: Industrial Freeze-Drying for Pharmaceutical Applications --
Chapter 16: Development of Process Data in a Pilot Plant Transferable to Production --
Chapter 17: Technical Procedures for Operation of Cleaning-in-Place/Sterilization-in-place Process for Production Freeze-Drying Equipment --
Chapter 18: Global Validation of Freeze-Drying Cycle Parameters by Using Integral HFT Systems --
Chapter 19: Lyophilizer Qualification: Some Practical Advice. Chapter 20: Lyophilization Process Validation --
Chapter 21: A New Development: Irradiation of Freeze-Dried Vaccine and Other Select Biological Products --
Chapter 22: Some Leading Edge Prospects in Lyophilization --
Index
UR  - http://repository.fue.edu.eg/xmlui/handle/123456789/1546
ER  -