General consideration of clinical drug strategies for antibody-drug conjugate development
10.13699/j.cnki.1001-6821.2024.24.030
- VernacularTitle:抗体偶联药物研发临床用药策略一般考虑
- Author:
Dan ZHANG
1
;
Lan-ping ZHONG
;
Yu-zhu WANG
Author Information
1. 国家药品监督管理局药品审评中心,北京 100022
- Publication Type:Journal Article
- Keywords:
antibody-drug conjugate;
dosing strategy;
dosage selection;
payload
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(24):3667-3672
- CountryChina
- Language:Chinese
-
Abstract:
Antibody-drug conjugate(ADC)has become one of the hot spots in the research and development of innovative anti-tumor drugs.Foreign and domestic regulatory agencies have issued relevant guidelines for the administration strategy of ADC drugs.This paper mainly discusses the concepts of dose exploration and optimization in the pre-marketing clinical research of ADC drugs from the aspects of molecular composition and indications of ADC drugs,hoping to provide references for domestic research and development of ADC drugs.
