Guidelines and strategy of the International Conference of Harmonization (ICH) and its member states to overcome existing impurity control problems for antibiotics in China / 中国天然药物
Chinese Journal of Natural Medicines (English Ed.)
;
(6): 498-506, 2015.
Artigo
em Inglês
| WPRIM
| ID: wpr-812517
ABSTRACT
In the present report, we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies, including the International Conference of Harmonization (ICH), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the China Food and Drug Administration (CFDA). Progresses with the US Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Chinese Pharmacopoeia (ChP) to control impurities in antibiotics are also presented. Next, our discussion is focused on analyzing the CFDA's requirements on impurity research and control for antibiotics, and the implementation of ICH, FDA and other technical guidelines for generic drugs impurity control in China. Existing problems are further reviewed, in order to improve the overall process for the control of antibiotic purity.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Farmacopeias como Assunto
/
Controle de Qualidade
/
Padrões de Referência
/
Pesquisa
/
Estados Unidos
/
United States Food and Drug Administration
/
Preparações Farmacêuticas
/
China
/
Contaminação de Medicamentos
/
Medicamentos Genéricos
Tipo de estudo:
Guia de Prática Clínica
/
Pesquisa qualitativa
Limite:
Humanos
País/Região como assunto:
América do Norte
/
Ásia
/
Europa
Idioma:
Inglês
Revista:
Chinese Journal of Natural Medicines (English Ed.)
Ano de publicação:
2015
Tipo de documento:
Artigo
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