title: Establishment of criteria for determining comparability of "well-characterized" proteins.
authors.affiliation: CBER, FDA, Bethesda, MD 20892, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Cavagnaro
mesh_terms: D001688:Biological Products / Q000302:isolation & purification* / Q000493:pharmacokinetics / Q000592:standards; D002626:Chemistry, Pharmaceutical; D006801:Humans; D011994:Recombinant Proteins / Q000302:isolation & purification* / Q000493:pharmacokinetics / Q000592:standards; D012449:Safety; D013810:Therapeutic Equivalency; D014116:Toxicology
chemical_list: D001688:Biological Products; D011994:Recombinant Proteins