Guidance for industry [electronic resource] : Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter.
Imprint
Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2009]
