Consideration on pre-clinical pharamacodynamic evaluation of non-alcoholic steatohepatitis innovative drugs
- VernacularTitle:非酒精性脂肪性肝炎创新药物非临床药效学研究的思考
- Author:
Shi-qi WANG
1
;
Na NING
1
;
Yu ZHOU
1
;
Mao-shan YIN
1
;
Yin WANG
1
;
Yi RONG
1
;
Wei ZHOU
1
;
Hong-yuan DA
1
;
Qing-li WANG
1
;
Xuan YE
1
Author Information
- Publication Type:Journal Article
- Keywords: non-alcoholic steatohepatitis; pre-clinical pharmacodynamic evaluation; animal model; liver fibrosis
- From: The Chinese Journal of Clinical Pharmacology 2024;40(22):3363-3368
- CountryChina
- Language:Chinese
- Abstract: Efficiency in pharmacodynamic study and evaluation is the critical issue in current drug research and development of non-alcoholic steatohepatitis(NASH).Resmetirom,the first marketed medicine for NASH,is approved by pathological surrogate endpoints,meanwhile several clinical trials suspended due to failure to achieve the liver histologic surrogate endpoints.The well-done non-clinical pharmacodynamic study basing on pathological features(ballooning degeneration,lobular inflammation,fibrosis)of NASH,is a great support to the whole research and development projects of new medicines for NASH.In this article,we discussed the necessity and feasibility of the NASH non-clinical pharmacodynamic study combining the clinical trials of NASH drug,the pathological features and the animal models of NASH,in order to facilitate the high-quality research and development of NASH drugs.
