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Best practices for evaluation of bone marrow in nonclinical toxicity studies

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Abstract:

Abstract:

This manuscript is intended to provide a best practice approach to accurately and consistently assess toxicant-induced bone marrow effects of test articles. In nonclinical toxicity studies, complete blood count data in conjunction with the histological examination of the bone marrow are recommended as the foundation for assessing the effect of test articles on the hematopoietic system. This approach alone can be used successfully in many studies. However, in some situations it may be necessary to further characterize effects on the different hematopoietic lineages, either by cytological or flow cytometric evaluation of the bone marrow. Both modalities can be used successfully, and which one is selected will depend on the expertise, preference of the facility, and the nature of the change in the bone marrow. Other specialized techniques such as clonogenic assays or electron microscopy are used rarely to further characterize hematotoxicity. The indications and techniques to successfully employ histological, cytological, or flow cytometric evaluation as well as clonogenic assays and electron microscopy are reviewed. William J. Reagan, Armando Irizarry-Rovira, Florence Poitout-Belissent, Anne Provencher Bolliger, Shashi K. Ramaiah, Greg Travlos, Dana Walker, Denise Bounous, and Gail Walter. "Best Practices for Evaluation of Bone Marrow in Nonclinical Toxicity Studies." Toxicologic Pathology (39.2) pp. 435-448, copyright 2011 by The Author(s), Reprinted by Permission of SAGE Publications Inc.

Keywords: Bone marrow; best practice; cytology; flow cytometry; histopathology

Document Type: Research Article

DOI: https://doi.org/10.1111/j.1939-165X.2011.00323.x

Affiliations: 1: Pfizer, Inc., Groton, Connecticut, USA 2: Eli Lilly and Company, Inc., Indianapolis, Indiana, USA 3: Charles River Laboratories, Senneville, Québec, Canada 4: Charles River Laboratories, Sherbrooke, Québec, Canada 5: Pfizer, Inc., Cambridge, Massachuesettes, USA 6: NIEHS, Research Triangle Park, North Carolina, USA 7: Bristol-Myers Squibb Co., Wallingford, Connecticut, USA 8: Bristol-Myers Squibb Co., Princeton, New Jersey, USA 9: Gail Walter, DVM, PLC, Kalamazoo, Michigan, USA

Publication date: 2011-06-01

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