ECU Libraries Catalog

Guidance for industry : comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information.

Other author/creatorCenter for Biologics Evaluation and Research (U.S.)
Other author/creatorCenter for Drug Evaluation and Research (U.S.)
Other author/creatorCenter for Veterinary Medicine (U.S.)
Format Electronic and Book
Publication InfoRockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Veterinary Medicine, [2003]
Descriptioniii, 19 : digital, PDF file.
Supplemental Content http://purl.access.gpo.gov/GPO/LPS113056
Subject(s)
Portion of title Comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information.
General noteTitle from PDF title page (viewed on May 26, 2009).
General note"Draft guidance".
General note"September 2003".
Technical detailsMode of access: Internet at the GPO Access web site. Address as of 5/26/09: http://www.fda.gov/cber/gdlns/protcmc.pdf ; current access is available via PURL.
GPO item number0499-T-02 (online)
Govt. docs number HE 20.4802:P 94/2

Available Items

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