Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program.
Bioanalysis
; 12(7): 431-443, 2020 Apr.
Article
em En
| MEDLINE
| ID: mdl-32343147
ABSTRACT
Aim:
To present the reader with different approaches used to compare immunogenicity methods when changes are needed during a clinical program.Results:
Five case studies are presented, in the first two case studies, the approach utilized a small sample size for the comparison. In the third case, all samples from a study were analyzed by both methods. In the fourth case, the intended use of noncomparable assays in an integrated summary drove design of experiments to establish the expected limits of pooling data. In the fifth case, a selectivity approach was used as an alternate to use of incurred samples.Conclusion:
When data pooling across methods is needed, it is important to define the limits of comparability.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Alergia e Imunologia
Limite:
Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article