Analysis of Quality Management of in Vitro Diagnostic Reagent Clinical Trials.
10.3969/j.issn.1671-7104.2020.05.013
- Author:
Man LYU
1
;
Dunyao BAI
1
;
Luan CHEN
1
;
Jieli LUO
1
Author Information
1. Center of Drug Clinical Trials, Puren Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, 430080.
- Publication Type:Journal Article
- Keywords:
clinical trial;
in vitro diagnostic reagent;
quality control
- MeSH:
Clinical Trials as Topic;
Indicators and Reagents/administration & dosage*;
Reagent Kits, Diagnostic
- From:Chinese Journal of Medical Instrumentation
2020;44(5):436-438
- CountryChina
- Language:Chinese
-
Abstract:
Clinical trial is an important step of in vitro diagnostic reagents research and development. Based on the Guiding Principles and the key points of inspect on the spot, combined with the actual work experience, the article focuses on the prominent problems in the whole process of in vitro diagnostic reagent clinical trials. It is helpful to improve the level of hospital drug clinical trial centre and the quality of in vitro diagnostic reagent clinical trials by analyzing the issues.
