Fixed Versus Body-Sized-Based Dosing of Monoclonal Antibodies.
Ann Pharmacother
; 58(1): 91-95, 2024 Jan.
Article
em En
| MEDLINE
| ID: mdl-37129243
ABSTRACT
Monoclonal antibody products are an increasing portion of novel drug approvals. The labeling of initial drug approvals frequently involves body-size-based rather than fixed-dose administration regimens for adults without clear rationale for doing so. This presents challenges when prescribing these products for patients with extremes of body habitus who constitute a small portion of enrollment in pre-approval investigations. Fixed-dose regimens allow for standardized preparation with the potential to reduce the risk of calculation errors, drug waste, and make home administration more practical. Fixed-dose rather than body-size-based monoclonal antibody regimens should serve as the initial approach in early phase 1 clinical trials.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Aprovação de Drogas
/
Anticorpos Monoclonais
Limite:
Adult
/
Humans
Idioma:
En
Revista:
Ann Pharmacother
Assunto da revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Estados Unidos