Metrics are discussed which are used for the evaluation of bioequivalence of modified-
release formulations. In order to ensure the therapeutic equivalence of the compared drug …

This report provides a summary of the 4 th International Conference on Global
Bioequivalence Harmonisation Initiative (GBHI) that was co-organised by the European …

This review describes the EMA requirements on biowaivers for additional strengths of
immediate release and modified release oral solid dosage forms focused on generic …

The principal goal of bioequivalence (BE) investigations has crucial importance and has
been the subject of extensive discussions. BE studies are frequently considered to serve as …

The requirement for multiple-dose bioequivalence studies for the approval of generic
prolonged-release (PR) formulations is not agreed upon by the EMA and FDA. While the …

(1) Background: this article investigates which PK metrics in a single-dose study
(concentration at the end of posology interval, Cτ, partial areas under the curve, pAUCs, or …

Bioavailability and bioequivalence study is one of the most frequently performed
investigations in clinical trials. Bioequivalence testing is based on the assumption that 2 …

To demonstrate bioequivalence (BE) between two prolonged-release (PR) drug
formulations, single dose studies under fasting and fed state as well as at least one steady …

Regulatory guidelines are necessary to standardize the evaluation procedure in
bioequivalence. Revisions in the guidelines occur in order to resolve any previously unclear …