S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use
Contributors: International Conference on Harmonisation
Publisher: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research
Published: 2008
Place of publication: Rockville, MD]
Language: eng
Format: [electronic resource]
Number of pages: 37
Subjects: Genetic toxicology; Drugs; Testing
Other titles: Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use; Genotoxicity testing and data interpretation for pharmaceuticals intended for human use
Notes: Title from title screen (viewed on June 17, 2009).

"ICH harmonized tripartite guideline"--P. 1.

"Draft January 28th 2008; version 5.3"--P. 1.

Includes bibliographical references (p. 35-37).

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.