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Title Guidance for industry [electronic resource] : comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information.

Imprint Rockville, 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]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:P 94/2    ---  Available
Description iii, 19 : digital, PDF file
System Details Mode of access via the GPO Access web site.
Note Title from PDF title page (viewed on May 26, 2009).
"Draft guidance".
"September 2003".
Subject Medical protocols -- Government policy -- United States.
Protein drugs -- United States.
Biological products -- Therapeutic use -- United States.
Added Author Center for Biologics Evaluation and Research (U.S.)
Center for Drug Evaluation and Research (U.S.)
Center for Veterinary Medicine (U.S.)
Added Title Comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information.
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:P 94/2

 
    
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