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Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter.

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Bibliographic Details
Corporate Authors: International Conference on Harmonisation, Center for Biologics Evaluation and Research (U.S.)
Format: Government Document Conference Proceeding eBook
Language:English
Published: [Rockville, Md.] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research] [date of publication not identified]
Subjects:
Drug monitoring.
Drugs > Microbiology > Testing.
Online Access:https://purl.fdlp.gov/GPO/LPS110458
Description
Item Description:Title from PDF title page (viewed on Mar. 20, 2009).
"Current step 2 version 1, dated 13 November 2008."
"Draft consensus guideline."
"Q4B annex 8."
Electronic resource.
Physical Description:10 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA Web site. Address as of 3/20/09: http://www.fda.gov/cder/guidance/8668dft.pdf ; current access is available via PURL.
Bibliography:Includes bibliographical references (page 2).