Case analysis of non-clinical study of thyroid C cells toxicity
10.13699/j.cnki.1001-6821.2018.19.037
- VernacularTitle:非临床甲状腺C细胞毒性的案例分析
- Author:
Hua-Jing YIN
1
;
Mao-Shan YIN
;
Yin WANG
;
Shuang WU
;
Zheng LI
;
Xiao-Min HU
Author Information
1. 国家食品药品监督管理总局 药品审评中心
- Keywords:
thyroid C cells;
glucagon -likepeptide1 receptor agonists;
carcinogenicity study;
medullary thyroid carcinoma
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(19):2376-2379
- CountryChina
- Language:Chinese
-
Abstract:
To explore the correlation between animal data that demonstra-ted potential thyroid C cells toxicity in non -clinical carcinogenicity stud-ies and clinical safety , in order to provide the basis for the non -clinical safety evaluation and clinical risks control .Summarized and untangled the carcinogenicity data and safety range of marketed drugs which could induce thyroid C cells tumors in non -clinical carcinogenicity studies , and analyszed the basis for approval .The correlation between animal thyroid C cells toxicity and human should be further studied .