Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Clin Transl Sci. 2020 Mar;13(2):219-223. doi: 10.1111/cts.12717. Epub 2019 Nov 25.
No abstract available

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adaptive Immunity / drug effects*
  • Biological Products / administration & dosage
  • Biological Products / immunology*
  • Drug Development / methods*
  • Drug Development / standards
  • Drug Monitoring / methods
  • Drug Monitoring / standards
  • Drug-Related Side Effects and Adverse Reactions / diagnosis
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Drug-Related Side Effects and Adverse Reactions / immunology*
  • Drug-Related Side Effects and Adverse Reactions / therapy
  • Humans
  • Models, Immunological*
  • Monitoring, Immunologic / methods
  • Monitoring, Immunologic / standards
  • Risk Assessment / methods
  • Risk Assessment / standards
  • Societies, Scientific / standards
  • United States
  • United States Food and Drug Administration / standards

Substances

  • Biological Products