chemical approaches / polysaccharide chain / chemical reagents / manufacturing changes / manufacturing conditions / active pharmaceutical ingredient / reference product / iterative chemical / abbreviated new drug applications / overall chemical composition / reference products / guidance Web page / modified drug product / Chemical structures / manufacturing process / /
U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Division of Dockets Management / office of Pharmaceutical Science / U.S. Securities and Exchange Commission / office of Communications Division of Drug Information / /
Person
Ion-Pair Chromatography / Daniela Verthelyi / Gallagher / Peter Safir / Douglas Throckmorton / / /