Establishment of criteria for determining comparability of "well-characterized" proteins.
Cavagnaro
J A
JA
CBER, FDA, Bethesda, MD 20892, USA.
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
D001688:Biological Products; D011994:Recombinant Proteins