A confidence interval is then constructed on basis of two one-sided t tests, typically at a nominal α level of 5%. Using non-compartmental analysis, the primary metrics derived in bioequivalence studies are most often the area under the concentration time curve until the last sampling point (AUCt) and the maximum observed concentration (Cmax) for both the test and the reference.
Throughout many countries and jurisdictions, the common way of testing for bioequivalence is to compare the pharmacokinetics of the new formulation (“test”) with that of the known formulation (“reference”).
Bioequivalence testing is a general requirement for companies developing generic medicines, testing food effects, making formulation changes, or developing extensions to existing approved medicines where absorption rate and extent to the systemic circulation determines safety and efficacy.
0 kommentar(er)
