Bioanalytical Methodology Validation
- VernacularTitle:生物样品分析中的方法学验证
- Author:
Jianping ZHANG
;
Cheng GUO
- Publication Type:Journal Article
- Keywords:
Bioanalysis;
Methodology validation;
Methodology quality control
- From:
China Pharmacy
2007;0(31):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To introduce the methodology validation and quality control in bioanalytical procedures and its expected trend of development.METHODS: According to the bioanalytical validation reflected in FDA guidelines and other publications,based on the guidance of SFDA and the standard operating procedure of our phase I clinical trial lab,we summarized the procedure and questions of bioanalytical methodology validation.RESULTS: The methodology validation and quality control in bioanalytical procedures and the possible risks involved in the methodology validation were summarized.CONCLUSIONS: The established methodology validation in bioanalytical procedure and quality control contents were basically consummate,but the standards for the methodology validation should be formulated based on reality.
