GEN covers the role of MDRS in reducing the need for clinical bioequivalence endpoint studies
This article followed the recent approval of an abbreviated new drug application (ANDA) for a locally-acting mometasone furoate nasal spray, which provided the opportunity for the US Food and Drug Administration (FDA) to highlight the pivotal and pioneering role MDRS played.
MDRS enables determination of the size and shape of specific components within a multi-component blend. For the purposes of the ANDA, this capability was used to compare the size of the active pharmaceutical ingredient (API) in the reference and test nasal sprays and confirm their close similarity. The resulting data were accepted in lieu of a clinical bioequivalence (BE) endpoint study, setting a precedent for future ANDAs – this could help reduce the cost and complexity of tests associated with a submission and accelerate new products to market.
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