期刊
JOURNAL OF IMMUNOLOGICAL METHODS
卷 418, 期 -, 页码 1-8出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jim.2015.01.008
关键词
Flow cytometry; Specimen stability; Anticoagulants; Cell stabilization; Biomarker; Clinical trials
The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. (C) 2015 Elsevier B.V. All rights reserved.
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