Guidance for industry : Q3A impurities in new drug substances.

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 InfoRockville, 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, [2008]
Description14 p. : digital, PDF file
Supplemental Contenthttps://purl.fdlp.gov/GPO/LPS113736
Subjects

Portion of title Q3A impurities in new drug substances
Portion of title Impurities in new drug substances
General noteTitle from PDF title page (viewed on June 15, 2009).
General note"ICH".
General note"June 2008".
General note"Revision 2".
General noteGPO Cataloging Record Distribution Program (CRDP).
Technical detailsMode of access: Internet at the FDA web site. Address as of 6/15/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127984.pdf; current access is available via PURL.
GPO item number0499-T (online)
Govt. docs number HE 20.4702:IM 7

Availability

Library Location Call Number Status Item Actions
Electronic Resources Access Content Online ✔ Available