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| LEADER |
02712nam a22003375i 4500 |
| 001 |
000294178 |
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20211014095601.0 |
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cr nn 008mamaa |
| 008 |
131012s2013 xxu| s |||| 0|eng d |
| 020 |
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|a 9781461479789
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| 024 |
7 |
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|a 10.1007/978-1-4614-7978-9
|2 doi
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| 040 |
|
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|a Sistema de Bibliotecas del Tecnológico de Costa Rica
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| 245 |
1 |
0 |
|a Sterile Product Development :
|b Formulation, Process, Quality and Regulatory Considerations /
|c edited by Parag Kolhe, Mrinal Shah, Nitin Rathore.
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| 250 |
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|a 1st ed. 2013.
|
| 260 |
# |
# |
|a New York, NY :
|b Springer New York :
|b Imprint: Springer,
|c 2013.
|
| 300 |
|
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|a XVI, 585 p. 89 illus., 67 illus. in color. :
|b online resource.
|
| 336 |
|
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|a text
|b txt
|2 rdacontent
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| 337 |
|
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|a computer
|b c
|2 rdamedia
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| 338 |
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|a online resource
|b cr
|2 rdacarrier
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| 490 |
1 |
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|a AAPS Advances in the Pharmaceutical Sciences Series,
|v 6
|
| 505 |
0 |
|
|a Basic Principles of Sterile Product Formulation Development -- Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins -- Polymer and Lipid Based Systems for Parenteral Drug Delivery -- Formulation Approaches and Strategies for PEGylated Biotherapeutics -- Nasal Delivery -- Formulation Approaches and Strategies for Vaccines and Adjuvants -- Challenges in Freeze-Thaw Processing of Bulk Protein Solutions -- Best Practices for Technology Transfer of Sterile Products: Case Studies -- Transfer Across Barrier Systems: A New Source of Simplification in Aseptic Fill and Finish Operations -- Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology -- Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals -- Advances in Container Closure Integrity Testing -- Pen and Autoinjector Drug Delivery Devices -- Particulate Matter in Sterile Parenteral Products -- Appearance Evaluation of Parenteral Pharmaceutical Products -- Sterile Filtration Principles, Best Practices and New Developments -- Intravenous Admixture Compatibility for Sterile Products: Challenges and Regulatory Guidance -- Basics of Sterilization Methods -- Avoiding Common Errors during Viable Microbial Contamination Investigations -- Validation of Rapid Microbiology Methods (RMMs) -- Validation of Moist and Dry Heat Sterilization.
|
| 650 |
|
0 |
|a Pharmaceutical technology.
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| 650 |
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0 |
|a Medicine.
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| 650 |
1 |
4 |
|a Pharmaceutical Sciences/Technology.
|
| 650 |
2 |
4 |
|a Biomedicine, general.
|
| 700 |
1 |
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|a Kolhe, Parag.
|e editor.
|
| 700 |
1 |
|
|a Shah, Mrinal.
|e editor.
|
| 700 |
1 |
|
|a Rathore, Nitin.
|e editor.
|
| 710 |
2 |
|
|a SpringerLink (Online service)
|
| 773 |
0 |
|
|t Springer eBooks
|
| 900 |
|
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|a Libro descargado a ALEPH en bloque (proveniente de proveedor)
|