A perspective on testing of existing pharmaceutical excipients for genotoxic impurities.
Regul Toxicol Pharmacol
; 55(2): 200-4, 2009 Nov.
Article
en En
| MEDLINE
| ID: mdl-19607870
ABSTRACT
Guidance recommendations by the Committee for Medicinal Products for Human Use (CHMP) and Pharmaceutical Research and Manufacturers of America (PhRMA) acknowledge the presence of potential toxic impurities in some pharmaceutical ingredients and have proposed setting limits on impurities with genotoxic activity as a means to protect patients in clinical trials and for marketing of the approved products. Recently, there have been suggestions that drug excipients, including existing products, should also be subjected to the same testing procedures and intake limits as proposed for active ingredients. This report is an attempt to put such recommendations into the proper perspective regarding the likelihood of protecting or improving public health.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Preparaciones Farmacéuticas
/
Contaminación de Medicamentos
/
Excipientes
/
Pruebas de Mutagenicidad
/
Mutágenos
Tipo de estudio:
Etiology_studies
/
Guideline
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Año:
2009
Tipo del documento:
Article