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RequestNotes

Status

From the Rare Disease TAUG

Rare Diseases Therapeutic Area User Guide, section 9.1, In Vivo Gene Therapy (Spinal Muscular Atrophy).

Status
colourGreen
titleResolved
  From the Rare Disease TAUG

  • Example added to the SDTMIG v4.0.



From Stefan Konermann.

Email from Stephen on 2023-09-01.

2023-09-07: 

  • Team agrees to add ISTEST = Cytokine-secreting T Cells
  • Team agrees to two ISCATs= VECTOR-INDUCED IMMUNOGENICITY and ANTIDRUG IMMUNOGENICITY.
  • Jordan to add this example to the SDTMIG v4.0. 
    Status
    colourYellow
    titleOpen Action Item

Status
colourGreen
title

in progress

Resolved
 



Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. An immunogenicity response may be wanted/desired or unwanted/undesired.

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