Biowaiver as a Bioequivalence Study Option

Biowaiver is a procedure for establishing the bioequivalence of generic and reference products without in vivo studies. Regulatory requirements this procedure, as described variety documents, differ certain features aspects. These differences need to be analysed. The aim study was compare international Russian regulatory approaches Biopharmaceutics Classification System-based biowaivers, provide recommendations on comparative dissolution testing, outline opportunities streamlining framework Eurasian Economic Union (EAEU).In article, authors analyse biowaiver describe procedures assessing permeability pH-dependent solubility medicines, comparing profiles various media that simulate gastrointestinal environment, interpreting test results. This paper shows role excipients an active substance. recommend methodological approach replacing studies with vitro tests under current EAEU list characteristics medicines limit applicability procedure. In conclusion, article provides rationale harmonising existing guidelines requirements.