Bioequivalence and Bioavailability Forum

Hi Hemant,

❝ On what basis we can prove that the study conducted outside European Union

❝ should have relevance of data to European population.

❝ Which factor should be considered to prove the same?

In my opinion this is not too much of an issue. Studies from other populations are generally well accepted in Europe, especially when we talk BE, and especially when we talk crossover. A trial conducted and presented in accordance with current standards and with acceptable confidence intervals etc is all it takes (although that can in itself be challenging enough to achieve).
Races etc generally are not believed to affect T/R. Although kinetic constants etc differ for certain drugs between populations (% genotype A, B and C within populations and so forth), there seems to be widespread agreement* that intrasubject variabilities do not suffer, and if they did then what? Do the trial in the population with the lowest varibility is a good guess, but since T/R seems unaffected, BE is expected to be proven in that population too when BE has been proven in a population with higher variability.

Best regards
EM.


*: Or lack of proof of the opposite.

Dear Hemant
Do you talk about clinical studies or BE studies? In case of clinical studies (or BA studies) you can not transfer data from other populations to European population without bridging studies. The objective of a bioequivalence study is, however, not the investigation of the pharmacokinetics of the drug entities itself, but the comparison of the pharmacokinetic profiles of galenic preparations. There is a wide experience that two formulations that were bioequivalent in one study population will also be bioequivalent in other populations (Rhodes CT: Generic substitution: Does interchangeability mean equality of all functional relevant attributes? Clin Res Reg Affairs (1995), 12(4): 267-272)
Kind regards
Dan