生物等效性试验质量管理的思考和实践

Ponderation and practice on the quality management of bioequivalence study

生物等效性试验是评价制剂质量的重要指标,有效的质量管理策略和措施是生物等效性试验设计和实施的重要考量。在某三级甲等医院生物等效性(预)试验质量管理中,常见以下问题:受试者不能完全依从方案、试验药物管理记录不完善、生物样本采集与管理违背方案或记录不详细、仪器设备管理不规范或记录不完整、试验数据记录不准确或逻辑不清。加强研究团队成员的沟通协作、完善制度文件体系建设、充分准备试验物资、细化试验操作程序并详细记录数据,有助于减少质量问题,提高试验实施质量,保证临床试验数据真实、可靠。

Bioequivalence study is an important index to evaluate the quality of preparations,and effective strategies and measures of quality management are important considerations in the design and implementation of bioequivalence studies.The problems frequently arising in the quality management of bioequivalence(pre)studies in grade 3A hospital:the subjects cannot fully comply with the protocol;the test drug management records are incomplete;the collection and management of biological samples violate the protocol or the records are not detailed;the management of instruments and equipment is not standardized or the records are incomplete;the records of test data are inaccurate or unclear.Strengthening the communication and cooperation among the members of the research team,perfecting the system construction of institutional documents,fully preparing test materials,refining test operation procedures and recording data in detail help to reduce quality problems,improve the quality of implementation of bioequivalence studies,and ensure the authenticity and reliability of the data.