S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use.
| Other author | Center for Drug Evaluation and Research (U.S.) |
| Other author | International Conference on Harmonisation. |
| Format | Electronic |
| Publication Info | [Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2008] |
| Description | 1 online resource (37 p.) |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS113857 |
| Subjects |
| Variant title | P. 1 has title: Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use |
| Portion of title | Genotoxicity testing and data interpretation for pharmaceuticals intended for human use |
| General note | Title from title screen (viewed on June 17, 2009). |
| General note | "ICH harmonized tripartite guideline"--P. 1. |
| General note | "Draft January 28th 2008; version 5.3"--P. 1. |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Bibliography note | Includes bibliographical references (p. 35-37). |
| Technical details | 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. |
| GPO item number | 0499-T (online) |
| Govt. docs number | HE 20.4702:G 28/2 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |