Module 9 2024

05/09/2024

Immunogencity Report

⚫ Sensitivity and appropriateness of assays and their fitness for purpose?

⚫ Comparison of ADAs, Nabs, titres, other.

Impact of ADAs on PK.

⚫

⚫ Impact of ADAs on PD across indications.

⚫ Impact of ADAs on efficacy across indications.

⚫ Is test indication sensitive to detect immunogenicity for all approved indication?

The Organisation for Professionals in Regulatory Affairs

57

INTERCHANGEABILITY

The Organisation for Professionals in Regulatory Affairs

58

29