Applications of drug interaction study in new drug development and regulartory decision-making
10.12092/j.issn.1009-2501.2021.10.001
- Author:
Bo SUN
1
;
Guiliang CHEN
1
;
Shujun FU
2
;
Li LI
2
Author Information
1. Shanghai Center for Drug Evaluation and Inspection
2. Center for Drug Evaluation, National Medical Products Adminstration, NMPA
- Publication Type:Journal Article
- Keywords:
Drug development;
Drug-drug interactions (DDI);
National Medical Products Administration;
Novel drug approvals;
US Food and Drug Administration
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2021;26(10):1095-1102
- CountryChina
- Language:Chinese
-
Abstract:
Drug-drug interactions (DDI) change dose-response relationships, and may result in low efficacy or high toxicity, which are important considerations especially in medical practice with multiple-drug therapies. Predicting clinically significant drug interactions during new drug development is an important part of benefit and risk assessment in drug development and review. This article summarizes the purpose and significance of drug interactions in new drug development, the main content and precautions of DDI studies in vivo and in vitro. Drug interaction studies on novel drug approvals for 2020 in the National Medical Products Administration (NMPA) and US Food and Drug Administration (USFDA) are examined, respectively. It aims to provide reference for DDI studies and regulatory reviews in new drug development in our country.
