CAJ | 학술논문

心肌肌钙蛋白I/肌红蛋白/肌酸激酶同工酶这三项指标是判断心梗的重要依据,目前该类定性体外诊断试剂尚无行业标准发布.本文从说明书、产品标准、临床试验等方面对该试剂盒审评工作中遵循的一些基本原则进行简要概述,以帮助注册申报人更好地把握产品的技术要点,有效指导注册申报工作.
심기기개단백I/기홍단백/기산격매동공매저삼항지표시판단심경적중요의거,목전해류정성체외진단시제상무행업표준발포.본문종설명서、산품표준、림상시험등방면대해시제합심평공작중준순적일사기본원칙진행간요개술,이방조주책신보인경호지파악산품적기술요점,유효지도주책신보공작.
@@@@Cardiac troponin I/myoglobin/creatine kinase isoenzyme is an important basis for myocardial infarction judgment, there is no industry standard is published for these qualitative in vitro diagnostic reagents. A brief overview of some basic principles in the evaluation about the brochures, the product standards, the clinical trials and other aspects describes in this paper. We hope it wil help the manufacturer grasp of the key points of the product and help the registration application effectively.