Bioequivalence and Bioavailability Forum

Dear Santhosh Kumar B
The term “Egyptian” refers to nationality which is irrelevant for the assessment of bioequivalence and other evaluation of drugs. You should focus on ethnicity which is one factor that may account for the observed differences in both pharmacokinetics (PK) and pharmacodynamics (PD) of drugs, resulting in variability in response to drug therapy. Ethnic diversity in drug response with respect to safety and efficacy and the resulting differences in recommended doses have been well described for some drugs. Some of these differential responses may be related to the pharmacogenomics of a particular drug. However, for a bioequivalence study especially conducted as an inter-subject comparison the clinical relevance of variability in drug response due to pharmacogenomics of drug-metabolizing enzymes does not need to be considered since there is a wide consensus that formulations which are bioequivalent in one study population will also be bioequivalent in other study populations.
Kind regards
Dr_Dan