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Lyophilization of Pharmaceuticals and Biologicals

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Cover of 'Lyophilization of Pharmaceuticals and Biologicals'

Table of Contents

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