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Guidance for industry : Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process.

Bibliographic Details
Corporate Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (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 Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
Subjects:
Biotechnological process monitoring.
Pharmaceutical biotechnology.
Biological products.
International Conference on Harmonisation.
Online Access:https://purl.fdlp.gov/GPO/LPS113768
Description
Item Description:Title from PDF title page (viewed on June 16, 2009).
Title from title screen (viewed on June 16, 2009).
"ICH".
"June 2005".
Electronic resource.
Physical Description:1 online resource (14 pages)
Format:Mode of access: Internet at the FDA web site. Address as of 6/15/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128076.pdf ; current access is available via PURL.
Bibliography:Includes bibliographical references (page 14).