Highlights from the 2020 AAPS 360 Annual Meeting

Rapid Fire Moderated by Mamta Kapoor (FDA), the first speaker was Heather Boyce (FDA), with a talk titled “Establishing Bioequivalence for ‘Additional Strengths’ of Oral Modified-Release Drug Products’. She described the FDA guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, that includes recommendations outlining approaches for establishing bioequivalence of additional strengths of a proposed modified release (MR) drug product for oral administration. Through two case studies of Bupropion HCl extended-release (ER) tablets and Venlafaxine HCl ER tablets, she illustrated that the FDA’s current thinking places less emphasis on compositional proportionality requirements than prior years. Whether a product is considered compositional or not, additional justification related to the proposed product release mechanism and excipient levels should be provided to use alternative methods to support and strengthen the bioequivalence study.