000 03421cam a22003614i 4500
999 _c2112
_d2112
001 13796179
005 20210816142758.0
008 041122s2004 nyua b 001 0 eng
020 _a0824748689
040 _aDLC
_cDLC
_dDLC
_erda
082 0 0 _a615.19
_222
_bF
245 0 0 _aFreeze-drying/lyophilization of pharmaceutical and biological products /
_cedited by Louis Rey, Joan C. May.
250 _aSecond edition. revised and expanded.
264 1 _aNew York :
_bMarcel Dekker,
_c[2004]
264 4 _c©2004
300 _avxvi, 613 pages :
_billustrations ;
_c24 cm
336 _2rdacontent
_atext
337 _2rdamedia
_aunmediated
338 _2rdacarrier
_avolume
490 1 _aDrugs and the pharmaceutical sciences ;
_v137
505 0 _aForeword -- 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.
650 0 _aFreeze-drying.
650 0 _aDrugs
_xDrying.
650 0 _aBiological products
_xDrying.
700 1 _aRey, Louis,
_98632
_eeditor.
700 1 _aMay, Joan C.,
_q(Joan Christine)
_98633
_eeditor.
830 0 _aDrugs and the pharmaceutical sciences ;
_vv. 137.
_98634
856 _3Abstract
_uhttp://repository.fue.edu.eg/xmlui/handle/123456789/1546
906 _a7
_bcbc
_corigcop
_d2
_encip
_f20
_gy-gencatlg
942 _2ddc
_cBK