Guidance for industry : Q1A(R2) stability testing of new drug substances and products.
| Other author | Center for Drug Evaluation and Research (U.S.) |
| Other author | Center for Biologics 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 : Center for Biologics Evaluation and Research, [2003] |
| Description | i, 22 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS113798 |
| Subjects |
| Portion of title | Q1A(R2) stability testing of new drug substances and products |
| Portion of title | Stability testing of new drug substances and products |
| General note | Title from PDF title page (viewed on June 16, 2009). |
| General note | "ICH". |
| General note | "November 2003". |
| General note | "Revision 2". |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Bibliography note | Includes bibliographical references (p. 21). |
| Technical details | Mode of access: Internet at the FDA web site. Address as of 6/16/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128204.pdf ; current access is available via PURL. |
| GPO item number | 0499-T (online) |
| Govt. docs number | HE 20.4702:ST 1/2 |