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An inter-laboratory retrospective analysis of immunotoxicological endpoints in non-human primates: Flow cytometry immunophenotyping.
MedLine Citation:
PMID:  23384295     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Abstract Non-human primates may be the only relevant species for pharmacology or toxicology studies of certain biologics, due to lack of activity in other species. Flow cytometry immunophenotyping is often included as a minimally invasive adjunct to standard toxicity testing. A retrospective inter-laboratory analysis was conducted to assess counts and variability of the main cell types monitored in toxicity studies, and to provide guidance for conduct and interpretation of immunophenotyping assessments in cynomolgus monkeys. Univariate and multivariate models were developed. Study design factors influencing cell counts and variability were identified and a power analysis was performed. Pre-study and on-study counts were generally similar; longitudinal analysis showed little drift in mean counts or within-animal variability over time. Within-animal variability was lower than inter-animal variability. Gender was associated with small but significant differences in mean counts and variability. Age was associated with significant differences in variability. Immunophenotype definitions were associated with significant differences in mean counts and within-animal variability for most cell types. Power analysis for groups of 6-8 animals showed that differences of ≈50% in counts of T-cells, T-cell subsets, and B-cells compared to pre-treatment values may be detected; for NK cells and monocytes, differences of ≈60-90% may be detected. This review yields some general points to consider for immunophenotyping studies, i.e. (a) analysis of log-transformed cell count data and comparisons using each animal as its own reference will improve ability to detect changes, (b) the magnitude of change detectable given study group size should be considered, (c) multiplication of sampling timepoints during a study seems unnecessary, (d) consideration should be given to using only one gender, when applicable, to increase power while minimizing animal usage, and (e) the choice of immunophenotype has impacts on cell counts and variability.
Authors:
Cecile M Krejsa; Moni Blazej Neradilek; Nayak L Polissar; Nick Cox; Darcey Clark; Laine Cowan; Jeanine Bussiere; Herve Lebrec
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-2-6
Journal Detail:
Title:  Journal of immunotoxicology     Volume:  -     ISSN:  1547-6901     ISO Abbreviation:  J Immunotoxicol     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-2-6     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101201960     Medline TA:  J Immunotoxicol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Applied Pharmacology LLC , Seattle, WA , USA.
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