[Toxicology studies for compound preparations of traditional Chinese medicine in ancient classic prescriptions].
Zhongguo Zhong Yao Za Zhi
; 47(23): 6529-6532, 2022 Dec.
Article
em Zh
| MEDLINE
| ID: mdl-36604900
ABSTRACT
According to Provisions for Drug Registration and Categories and Requirements of Application Dossiers for Traditional Chinese Medicine(TCM), non-clinical safety research/toxicology research should be conducted for classical compound Chinese medicine prescriptions(Categories 3.1 and 3.2), and the data should be submitted at the application for the marketing authorization. Based on the requirements of toxicology research in Categories and Requirements of Application Dossiers for Traditional Chinese Medicine, this study further refined and clarified the requirements of toxicology research on classical compound Chinese medicine preparations(Categories 3.1 and 3.2).
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Medicamentos de Ervas Chinesas
/
Medicina Tradicional Chinesa
Tipo de estudo:
Diagnostic_studies
Idioma:
Zh
Ano de publicação:
2022
Tipo de documento:
Article