Search results with tag "Immunogenicity testing"

Guideline on immunogenicity assessment of biotechnology ...

relevant modules. Depending on the immunogenic potential of the therapeutic protein and the rarity of the disease, the extent of immunogenicity data before approval might be limited. Further systematic immunogenicity testing might become necessary after marketing authorization, and may be included in the risk management plan.

  Testing, Therapeutic, Protein, Immunogenicity, Therapeutic protein, Immunogenicity testing