ANAEMIA IN THE MALE HEALTHY VOLUNTEERS PARTICIPATING IN BIOEQUIVALENCE STUDIES

Abstract

Author(s): Naqvi Syed Mujtaba Hussain*, V. Srividya, V. Gautham Kumar, C Vijayaram

Healthy male volunteers participate in bioequivalence studies conducted to establish the sameness between test and reference drugs. These studies involve loss of blood which adds to the already prevalent nutritional anemia in the volunteers. This study attempts to understand the magnitude and severity of anemia among the volunteers participating in bioequivalence studies. 100 laboratory reports of volunteers were randomly obtained and laboratory parameters were entered in case record forms. The results showed 52 % of volunteers were anemic with hemoglobin level less than 13 g/dl.