Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 3, Test for particulate contamination : subdivisible particles general chapter.
Imprint
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, [2009]
Mode of access: Internet from the CDER web site. Address as of 5/12/09: http://www.fda.gov/cder/guidance/8412fnl.pdf; current access available via PURL.
