Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
| 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 | iii, 20 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS111169 |
| Subjects |
| Portion of title | Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals |
| General note | Title from PDF title page (viewed on Apr. 9, 2008). |
| General note | "ICH harmonised tripartate guideline." |
| General note | "M3(R2)." |
| General note | "Current step 2 version dated 15 July, 2008." |
| General note | Includes bibliographical references (p. 19-20). |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Technical details | Mode of access: Internet at the FDA CBER Web site. Address as of 4/09/09: http://www.fda.gov/cder/guidance/8500dft.pdf ; current access is available via PURL. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:N 73 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |