Retrospective thinking on non-clinical safety evaluation of endocrine indication polypeptide drugs
10.13699/j.cnki.1001-6821.2024.23.028
- VernacularTitle:内分泌适应证多肽药物非临床安全性评价的回顾性思考
- Author:
Mao-shan YIN
1
;
Hui LI
;
Tian-tian DOND
;
Zheng LI
;
Hua-jing YIN
;
Yin WANG
;
Shuang WU
;
Hua-chen ZHAO
;
Bing YU
;
Hong-yuan DA
Author Information
1. 国家药品监督管理局药品审评中心,北京 100163
- Publication Type:Journal Article
- Keywords:
peptide drug;
endocrine indication;
non-clinical safety evaluation;
consideration;
retrospective thinking
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(23):3501-3508
- CountryChina
- Language:Chinese
-
Abstract:
Polypeptide drugs have attracted much attention in the field of drug research and development due to their wide range of indications,especially in pharmaceutical R&D of new drugs with endocrine related indications such as diabetes and osteoporosis.With the advancement of peptide synthesis and delivery technologies,the research and application of peptide drugs have made significant breakthroughs.However,the R&D and nonclinical safety assessment of peptide drugs still face many challenges,and there are no specific guidelines for the nonclinical safety evaluation of this class of drugs domestically or abroad.This article focuses on the field of endocrine indications.By analyzing the nonclinical studies of approved peptide drugs,and considering the current R&D status and specific regulatory requirements,this paper proposes considerations on the nonclinical safety assessment of peptide drugs,including the selection of relevant animal species,key study contents,specific considerations for peptides containing non-natural amino acids,etc.The aims are to provide references for optimizing and improving the nonclinical safety evaluation of peptide drugs.
