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02539nam a22003255i 4500 |
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20210506133224.0 |
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cr nn 008mamaa |
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130217s2013 xxu| s |||| 0|eng d |
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|a 9781461459507
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| 024 |
7 |
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|a 10.1007/978-1-4614-5950-7
|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 Global Approach in Safety Testing :
|b ICH Guidelines Explained /
|c edited by Jan Willem van der Laan, Joseph J DeGeorge.
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| 250 |
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|a 1st 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 XII, 315 p. 16 illus., 13 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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| 490 |
1 |
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|a AAPS Advances in the Pharmaceutical Sciences Series,
|v 5
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| 505 |
0 |
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|a The International Conference on Harmonisation. History of Safety Guidelines -- EU Perspective on ICH -- The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities Advancing Harmonization for Better Public Health -- A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process -- Towards more Scientific Relevance in Carcinogenicity Testing -- The Evolution, Scientific Reasoning and Use of ICH S2 Guidelines for Genotoxicity Testing of Pharmaceuticals -- Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies , Where are we now; an S3A/S3B update (1995-2011) -- Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B) -- Why and how did Reproduction Toxicity Testing make its early entry into and Rapid Success in ICH? -- ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals -- Safety Pharmacology: Guidelines S7A and S7B -- ICH S8: History and Perspectives -- ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals a Perspective from Regulators on the Development of the Guideline -- Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals ICH M3 and M3(R2).
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| 650 |
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0 |
|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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| 700 |
1 |
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|a van der Laan, Jan Willem.
|e editor.
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| 700 |
1 |
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|a DeGeorge, Joseph J.
|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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| 900 |
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|a Libro descargado a ALEPH en bloque (proveniente de proveedor)
|