The series of conferences of the Global Bioequivalence Harmonisation Initiative (GBHI) was
started in 2015 by the European Federation for Pharmaceutical Sciences (EUFEPS). All …

Regulatory authorities introduced procedures in the last decade for evaluating the
bioequivalence (BE) for highly variable drugs. These approaches are similar in principle but …

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology,
Second Edition explores statistics used in day-to-day clinical pharmacology work. The book …

Purpose To verify previously reported findings for the European Medicines Agency's method
for Average Bioequivalence with Expanding Limits (ABEL) for assessing highly variable …

We previously demonstrated pharmacokinetic differences among manufacturing batches of
a US Food and Drug Administration (FDA)‐approved dry powder inhalation product (Advair …

Bioequivalence (BE) of products containing narrow therapeutic index (NTI) drugs in the
European Union is currently established by demonstrating that the 90% confidence interval …

Average (bio) equivalence tests are used to assess if a parameter, like the mean difference
in treatment response between two conditions for example, lies within a given equivalence …

Purpose: More than a decade ago the option to assess highly variable drugs/drug products
by reference-scaled average bioequivalence was introduced in regulatory practice …

Reference‐scaled average bioequivalence (RSABE) approaches for highly variable drugs
are based on linearly scaling the bioequivalence limits according to the reference …

Abstract The Global Bioequivalence Harmonization Initiative (GBHI) was launched by the
Network on Bioavailability and Biopharmaceutics (BABP) under the auspices of European …