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Guidance for industry : validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products.

Bibliographic Details
Corporate Author: 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 Biologics Evaluation and Research, [2008]
Subjects:
Cellular therapy > Testing.
Gene therapy > Testing.
Rapid methods (Microbiology)
Online Access:https://purl.fdlp.gov/GPO/LPS111982
Description
Item Description:Title from PDF title page (viewed on Apr. 28, 2009).
"Draft guidance".
"February 2008".
Includes bibliographical references (page 12).
Electronic resource.
Physical Description:i, 12 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA CBER Web site. Address as of 4/28/09: http://connexion.oclc.org/WebZ/CorcSCAN?sessionid=cnxs04.prod.oclc.org-38204-fu2vwnqz-d2g4oh ; current access is available via PURL.