Differences in bioanalytical method validation for biologically derived macromolecules (biosimilars) compared with small molecules (generics)

Bioanalysis

Volumn 3, Issue 14, 2011, Pages 1551-1553

  Oldfield, Philip ^a  

^a NONE   (Canada)

Author keywords

biosimilar; glycosylation; immunoassay; immunogenicity; innovator drug; Pharmacokinetics; potency

Indexed keywords

GENERIC DRUG;

ABSORPTION; ANALYTIC METHOD; BIOAVAILABILITY; BIOEQUIVALENCE; BIOSIMILAR; CALIBRATION; DRUG DOSAGE FORM COMPARISON; FOOD AND DRUG ADMINISTRATION; GENETIC HETEROGENEITY; GLYCOSYLATION; IMMUNOASSAY; IMMUNOGENICITY; IMMUNOREACTIVITY; MACROMOLECULE; MASS SPECTROMETRY; PROTEIN PROCESSING; REVIEW; VALIDATION PROCESS;

EID: 79960550242     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.129     Document Type: Review

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