| Recommendations for the validation of flow cytometric testing during drug development: II assays. | |
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MedLine Citation:
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PMID: 20946898 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Flow cytometry-based assays serve as valuable tools for various aspects of the drug development process ranging from target discovery and characterization to evaluation of responses in a clinical setting. The integrity of the samples and the appropriate selection and characterization of the reagents used in these assays are in themselves challenging. These concerns taken together with the flow-based technology makes the validation of flow cytometry assays a challenging effort. Therefore, apart from summarizing the role of flow cytometry technology in various stages of drug development, this manuscript focuses on recommendations for the validation of methods applying flow cytometry. Information is also provided on the relevant validation parameters for different types of flow cytometry assays to guide the users of this platform. Together, the recommendations and the information on regulatory guidelines provided in this manuscript represent the consensus of all the authors and can assist the flow cytometry user in implementing the appropriate method validation strategies. |
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Authors:
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Denise M O'Hara; Yuanxin Xu; Zhiyan Liang; Manjula P Reddy; Dianna Y Wu; Virginia Litwin |
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Publication Detail:
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Type: Journal Article; Review Date: 2010-10-11 |
Journal Detail:
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Title: Journal of immunological methods Volume: 363 ISSN: 1872-7905 ISO Abbreviation: J. Immunol. Methods Publication Date: 2011 Jan |
Date Detail:
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Created Date: 2010-12-17 Completed Date: 2011-01-24 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 1305440 Medline TA: J Immunol Methods Country: Netherlands |
Other Details:
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Languages: eng Pagination: 120-34 Citation Subset: IM |
Copyright Information:
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Copyright © 2010 Elsevier B.V. All rights reserved. |
Affiliation:
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Pharmacokinetics, Dynamics and Metabolism, Pfizer (formerly Wyeth), 35 Cambridge Park Drive, Cambridge, MA 02140, USA. Denise.O'Hara@pfizer.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Drug Discovery
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methods,
standards* Flow Cytometry / instrumentation, methods, standards* Fluorescent Antibody Technique / instrumentation, methods, standards* Pharmaceutical Preparations / analysis*, standards Reproducibility of Results Validation Studies as Topic |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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