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E-Book/E-Doc

Conference

International Conference on Harmonisation.

Title Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter [electronic resource].

Imprint

[Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research]

Connect to
Connect to https://permanent.fdlp.gov/lps110458/ucm085370.pdf

Copies

Location	Call No.	OPAC Message	Status
Axe Federal Documents Online	HE 20.4802:P 49/4	---	Available

Description	10 p. : digital, PDF file
System Details	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.
Note	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."
Bibliography	Includes bibliographical references (p. 2).
Subject	Drug monitoring.
	Drugs -- Microbiology -- Testing.
Added Author	Center for Biologics Evaluation and Research (U.S.)
Added Title	ICH regions on Sterility Test General Chapter
Cover Title	Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions
Gpo Item No.	0499-T-02 (online)
Sudoc No.	HE 20.4802:P 49/4