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

Bibliographic Details
Corporate Authors: Center for Biologics Evaluation and Research (U.S.), Center for Drug Evaluation and Research (U.S.), Center for Veterinary Medicine (U.S.)
Format: Government Document eBook
Language:English
Published: 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]
Subjects:
Medical protocols > Government policy > United States.
Protein drugs > United States.
Biological products > Therapeutic use > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS113056
Description
Item Description:Title from PDF title page (viewed on May 26, 2009).
"Draft guidance".
"September 2003".
Electronic resource.
Physical Description:iii, 19 : digital, PDF file.
Format:Mode 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.