Monoclonal and engineered antibodies for human parenteral clinical use: regulatory considerations.
Manohar
V
V
Laboratory of Cell Biology, US Food and Drug Administration, Bethesda, MD 20892.
Hoffman
T
T
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000235:genetics / Q000627:therapeutic use*; D001709:Biotechnology; D006801:Humans; D015202:Protein Engineering; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
D000911:Antibodies, Monoclonal