Report on the AAPS Immunogenicity Guidance Forum.
AAPS J
; 21(4): 55, 2019 04 16.
Article
em En
| MEDLINE
| ID: mdl-30993501
ABSTRACT
In September 2018, the American Association of Pharmaceutical Scientists (AAPS) conducted an Annual Guidance Forum on the considerations related to immunogenicity testing for therapeutic protein products. In addition to a broad representation by the pharmaceutical industry, the event included strong representation by leading scientists from the US Food and Drug Administration (FDA). The agency and industry perspectives and updates to the guidance were presented. Specific topics that were discussed included the strategies of anti-drug antibody (ADA) assay cut-point assessments, the selection of ADA-positive controls (PCs), and the evaluation of PC performance. Assessment strategies and relevance of ADA assay attributes were also discussed, including assay drug tolerance and ADA assay sensitivity. The following is a summary of the discussion.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Produtos Biológicos
/
Proteínas
/
Guias como Assunto
/
Anticorpos
Tipo de estudo:
Guideline
Limite:
Animals
País/Região como assunto:
America do norte
Idioma:
En
Revista:
AAPS J
Ano de publicação:
2019
Tipo de documento:
Article