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�й�ҩѧ��־ 2014, Vol. 49 Issue (13) :1176-1180    DOI: 10.11669/cpj.2014.13.020
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CHEN Xiao-yan1,2, ZHAN Yan1, ZHONG Da-fang1, 2*
1.Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China;
2.China Bioanalysis Forum, Shanghai 201203, China

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ժҪ Ŀ�� ����������Ʒ�ٷ���(incurred sample reanalysis�� ISR)�ķ���Ҫ������ͶԲߡ����� ���������Ϲ���������Ʒ�ٷ�����ָ��ԭ���о����ĺ�ͳ�����ݣ�ͨ��ʵ�����ܽ�������Ʒ�ٷ���ʧ�ܵ�ԭ��Ԥ����ʩ���������� ������Ʒ�ٷ��������ڸ���������������������ԣ��Ѿ���Ϊ����������Ʒ������һ����Ҫ���ݡ���ȡ�ʵ��ĶԲߣ����Է�ֹ������Ʒ�ٷ���ʧ����ɵ���ʧ��
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Abstract�� OBJECITVE To we summarize the background, evolution and implementation of incurred sample reanalysis (ISR) for bioanalysis. METHODS Based on the available guidance documents, research papers and statistical data, some selected case studies are outlined to help understand the root causes of ISR failures and how to prevent and correct the errors. RESULTS AND CONCLUSION ISR program may improve the reproducibility of bioanalytical assays, and has become an integral part of regulatory guidance. To avoid ISR failure, precautions must be taken in the early stage of method development.
Keywords�� incurred sample reanalysis,   bioanalytical method validation,   quantification reproducibility,   regulatory bioanalysis     
�ո�����: 2014-09-03;
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��Ц��, , ղ���� .������Ʒ��������������֤��������Ʒ�ٷ���������ͶԲ�[J]  �й�ҩѧ��־, 2014,V49(13): 1176-1180
CHEN Xiao-Yan-, , ZHAN Yan- etc .Significance and Implementation Strategy of Incurred Sample Reanalysis in Bioanalytical Method Validation[J]  Chinese Pharmaceutical Journal, 2014,V49(13): 1176-1180
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