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harmacokinetics based BE study is a good tool primarily used as
regulatory testing for establishing equivalence of a formulation for
ANDA application. Examining the underlying science behind BE testing,
one can see that it is an excellent tool to study population genetics,
particularly, inter-individual variations and inter-population variations.
The pharmacokinetics based phenotypic variations can be correlated
with genotype and such correlations can be used for predicting efficacy
The presentation will include data from BE study of several drugs,
inter-individual variability observed in many cases, genotyping of the
volunteers for several drug metabolizing enzymes (DMEs), correlation
between genotype and phenotype (Cmax and AUC). The presentation
will illustrate use of BE data to understand ADME ?population? as well
as ?individual? and will demonstrate link between BA/BE and the newly
emerged science of Pharmacogenetics.
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