Review
Open access
Sep 2026
From ADA positivity to clinical decision: a context-of-use framework for reflex testing, sampling frequency and stopping rules in immunogenicity assessment.
A context-of-use framework for immunogenicity assessment is proposed for ADA testing, which should be designed around decisions it is expected to support, including pharmacokinetics/, pharmacodynamics (PK/PD) interpretation, efficacy, safety, labeling, dose selection, treatment interruption, and development progression...
Ahmad Z. Al Meslamani, A. Jarab, H. El Sharu et al.
· Bioanalysis · 0 citations