Table 1.

Requirements for oral immediate release bioequivalence demonstration

Criterion	Detail
BCS classification	Outlining the documented class and any necessary background information on solubility or permeability, taking into consideration if a Biopharmaceutics Classification System (BCS) based biowaiver is possible.
Bioequivalence study design	Design features generally include the study design and population, number of studies required, conditions of administration (fasting/fed or both) and strength(s) to be investigated.
Analyte	Type of analyte to be measured and the medium to be investigated, also whether an enantioselective analytical method is required.
Bioequivalence assessment	The main pharmacokinetic variables required to demonstrate bioequivalence and the related acceptance criteria.