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100710s2009 xxu| s |||| 0|eng d |
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|a 9780387856278
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| 024 |
7 |
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|a 10.1007/978-0-387-85627-8
|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 Handbook of Stability Testing in Pharmaceutical Development :
|b Regulations, Methodologies, and Best Practices /
|c edited by Kim Huynh-Ba.
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| 250 |
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|a 1st ed. 2009.
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| 260 |
# |
# |
|a New York, NY :
|b Springer New York :
|b Imprint: Springer,
|c 2009.
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| 300 |
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|a XVII, 389 p. 72 illus. :
|b online resource.
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| 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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| 505 |
0 |
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|a Stability Regulations -- Critical Regulatory Requirements for a Stability Program -- Understanding ICH Guidelines Applicable to Stability Testing -- Global Stability Practices -- Post-approval Changes – Stability Requirements and Regulations -- Understanding and Predicting Pharmaceutical Product Shelf-Life -- Stability Methodologies and Best Practices -- Development of Stability Indicating Methods -- Method Validation and Transfer -- Overview of USP-NF Requirements for Stability Purposes -- Non-chromatographic Methods to Support Stability Program -- Vibrational Spectroscopic Methods for Quantitative Analysis -- Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product -- Evaluation of Stability Data -- Qualification, Calibration, and Maintenance of Stability Chambers -- Stability Operation Practices -- Other Stability Programs -- Combination Products/Drugs in Devices -- Stability Studies for Biologics.
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| 650 |
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|a Toxicology.
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| 650 |
1 |
4 |
|a Pharmacology/Toxicology.
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| 700 |
1 |
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|a Huynh-Ba, Kim.
|e editor.
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| 710 |
2 |
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|a SpringerLink (Online service)
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| 773 |
0 |
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|t Springer eBooks
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