Glycoprotein pharmaceuticals: scientific and regulatory considerations, and the US Orphan Drug Act.
Division of Biochemistry and Biophysics, Department of Health and Human Services, Food and Drug Administration, Bethesda, MD 20892.
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D000818:Animals; D004345:Drug Industry; D006023:Glycoproteins / Q000276:immunology / Q000378:metabolism / Q000627:therapeutic use*; D006031:Glycosylation; D013006:Growth Hormone; D006801:Humans; D007880:Legislation, Drug; D009965:Orphan Drug Production / Q000331:legislation & jurisprudence*
D006023:Glycoproteins; D013006:Growth Hormone