| Foreword |
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v | |
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| Preface |
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vii | |
| Contributors |
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xi | |
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1 Glimpses into the Realm of Freeze-Drying: Classical Issues and New Ventures |
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1 | (28) |
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2 Structural and Dynamic properties of Bulk and Confined Water |
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29 | (23) |
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Marie-Claire Bellissent-Funel |
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3 Freezing and Annealing Phenomena in Lyophilization |
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52 | (30) |
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4 Phase Separation of Freeze-Dried Amorphous Solids: The Occurrence and Detection of Multiple Amorphous Phases in Pharmaceutical Systems |
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82 | (30) |
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5 The use of Microscopy, Thermal Analysis, and Impedance Measurements to Establish Critical Formulation Parameters for Freeze-Drying Cycle Development |
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112 | (24) |
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6 The Relevance of Thermal Properties for Improving Formulation and Cycle Development: Application to Freeze-Drying of Proteins |
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136 | (31) |
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7 Freezing-and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives |
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167 | (31) |
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8 Mechanisms of Protein Stabilization During Freeze-Drying Storage: The Relative Importance of Thermodynamic Stabilization and Glassy State Relaxation Dynamics |
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198 | (35) |
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9 Formulation Characterization |
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233 | (21) |
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10 Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Nonaqueous Cosolvent Systems |
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254 | (34) |
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11 Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture |
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288 | (29) |
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12 Freeze-Drying of Biological Standards |
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317 | (37) |
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13 Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation Times, and Its Effect on Storage Stability |
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354 | (18) |
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14 Scanning Electron Microscopy: A Powerful Tool for Imaging Freeze-Dried Material |
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372 | (11) |
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15 Pharmaceutical Packaging for Lyophilization Applications |
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383 | (13) |
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16 Closure and Container Considerations in Lyophilization |
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396 | (17) |
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17 Extractables and Leachables as Container Closure Considerations in Loyphilization |
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413 | (12) |
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18 Optimizing the Throughput of Freeze-Dryers Within a Constrained Design Space |
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425 | (16) |
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19 Monitoring and Control of Industrial Freeze-Drying Operations: The Challenge of Implementing Quality-by-Design (QbD) |
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441 | (19) |
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20 Process Analytical Technology in Industrial Freeze-Drying |
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460 | (34) |
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21 Practical Considerations for Freeze-Drying in Dual Chamber Package Systems |
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494 | (33) |
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22 Lyophilization and Irradiation as an Intergrated Process |
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527 | (14) |
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| Appendix: Table, Saturation Vapor Pressure of Ice |
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541 | (4) |
| Index |
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545 | |
