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PI‐7
Author(s) -
Adams L.,
Wilbraham D.,
Mant T.
Publication year - 2006
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2005.12.028
Subject(s) - ethnic group , range (aeronautics) , afro caribbean , medicine , demography , gerontology , anthropology , political science , sociology , engineering , law , aerospace engineering
A retrospective analysis was performed on laboratory results obtained from 21 healthy male subjects of Afro‐Caribbean origin. The purpose of the study was to compare these volunteers to a standard phase 1 unit reference range and to observe any differences. Pre‐dose data was obtained from Afro‐Caribbean subjects who had participated in phase 1 studies at Guy's Drug Research Unit, Quintiles over the last year. Blood samples were obtained for biochemistry, haematology, urinalysis and coagulation profile. The samples were analysed in‐house and the results compared to a valid reference range (not adjusted for ethnicity). No significant differences were noted observed on reviewing results for serum liver enzymes, urea and creatinine, clotting profile and urinalysis. In Afro‐Caribbean subjects, the total white blood counts were relatively low, the differential neutrophil count was also relatively low and serum sodium concentrations were relatively high. The mean serum creatine phosphokinase (CPK) was approximately 2,6 times higher than the mean reference range CPK. Ethnicity should be considered when reviewing laboratory data in healthy male volunteer studies. Clinical Pharmacology & Therapeutics (2005) 79 , P8–P8; doi: 10.1016/j.clpt.2005.12.028