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2. EMA Guideline on the investigation of bioequivalence (CPMP/QWP/EWP/1401/98 Rev. 1, 2010).
3. Health Canada Guidance Document: Biopharmaceutics Classification System Based Biowaiver, 2014.
4. ICH Final endorsed Concept Paper M9: Biopharmaceutics Classification System-based Biowaivers, 7 October 2016. .
5. In vivo methods for drug absorption – comparative physiologies, model selection, correlations with in vitro methods (IVIVC), and applications for formulation/API/excipient characterization including food effects;Sjögren;Eur. J. Pharm. Sci.,2014