S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use

Other Authors: Center for Drug Evaluation and Research (U.S.), International Conference on Harmonisation.
Format: Electronic
Language: English
Published: [Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2008]
Physical Description: 1 online resource (37 pages)
Subjects:
Online Access: https://purl.fdlp.gov/GPO/LPS113857
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246 1 |i P. 1 has title:  |a Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. 
246 3 0 |a Genotoxicity testing and data interpretation for pharmaceuticals intended for human use. 
264 1 |a [Rockville, MD] :  |b U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,  |c [2008] 
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538 |a Mode of access: Internet at the FDA web site. Address as of 6/17/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129117.pdf ; current access is available via PURL. 
500 |a Title from title screen (viewed on June 17, 2009). 
500 |a "ICH harmonized tripartite guideline"--P. 1. 
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504 |a Includes bibliographical references (pages 35-37). 
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650 0 |a Drugs  |x Testing. 
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711 2 |a International Conference on Harmonisation. 
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