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130507s2013 xxu| s |||| 0|eng d |
| 020 |
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|a 9781461469162
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| 024 |
7 |
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|a 10.1007/978-1-4614-6916-2
|2 doi
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| 040 |
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|a Sistema de Bibliotecas del Tecnológico de Costa Rica
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| 100 |
1 |
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|a Geigert, John.
|e author.
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| 245 |
1 |
4 |
|a The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics /
|c by John Geigert.
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| 250 |
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|a 2nd ed. 2013.
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| 260 |
# |
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|a New York, NY :
|b Springer New York :
|b Imprint: Springer,
|c 2013.
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| 300 |
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|a XXIX, 338 p. 24 illus., 17 illus. in color. :
|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 Complexity of Biologica CMC Regulation -- Biologics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Source Materials for Biologics -- Manufacture of the Biologic API -- The Biologic Final Product Process -- Complex Process-Related Impurities -- Molecular Structural Analysis -- Functional Activity (Potency) -- Setting Specifications and Expiry Dates -- Demonstrating Product Comparability -- CMC-Focused Regulatory Meetings -- References.
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| 650 |
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|a Pharmaceutical technology.
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| 650 |
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|a Medicine.
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| 650 |
1 |
4 |
|a Pharmaceutical Sciences/Technology.
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| 650 |
2 |
4 |
|a Biomedicine, general.
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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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| 900 |
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|a Libro descargado a ALEPH en bloque (proveniente de proveedor)
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