On safety margin for drug interchangeability.
J Biopharm Stat
; 27(2): 293-307, 2017.
Article
em En
| MEDLINE
| ID: mdl-27911675
ABSTRACT
As more and more generic (or biosimilar) drug products become available in the market place, it is a concern whether the approved generic (or biosimilar) drug products are safe and efficacious and hence can be used interchangeably. According to current regulation, most regulatory agencies such as the United States Food and Drug Administration (FDA) indicate an approved generic (or biosimilar) drug product can serve as a substitute for the innovative drug product. Bioequivalence (biosimilarity) assessment for regulatory approval among generic copies (or biosimilars) of the innovative drug product are not required. In practice, approved generic (or biosimilar) drugs are commonly used interchangeably without any mechanism of safety monitoring. In this article, current bioequivalence (or biosimilarity) limit is adjusted according to the observed geometric mean ratio and corresponding variability for development of safety margins for monitoring of drug interchangeability by minimizing the relative change in response with and without the switching.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Equivalência Terapêutica
/
Medicamentos Genéricos
/
Medicamentos Biossimilares
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article