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Title Q4B, annex 3, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination, sub-visible particles [electronic resource] / International Conference on Harrmonisation of Technical Requrements for Registration of Pharmaceuticals for Human Use.

Imprint [Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research , 2007]
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Connect to https://permanent.fdlp.gov/lps112085/ichq4bann3.pdf

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:P 25/2    ---  Available
Description [7] p. : digital, PDF file
System Details Mode of access via the FDA CBER web site.
Note Title from PDF title page (viewed on Apr. 30, 2009).
"Draft consensus guideline".
"Current step 2 version, dated November 1, 2007".
Bibliography Includes bibliographical references: (p. [4]).
Subject Drugs -- Microbiology -- Testing.
Added Author Center for Biologics Evaluation and Research (U.S.)
International Conference on Harmonisation.
Added Title Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination, sub-visible particles
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:P 25/2

 
    
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