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• Published Subscription 28 Feb 2019

  A Brief Note on Different Concept of Biowaiver

  By Mudit Dixit, Rohit Dixit, Vasanth Samaga, Ganapayya Bairy, Ajay Bairy

  Abstract: The aim of the present work was to understand the concept of to waive a complete and systemic bioequivalence (BE) study. Biowaiver or request for a biowaiver is a fast track approach to boost the drug development process. Over the past three-four years, the biowaiver market has shown greater number of biowaiver submissions and the wider use of in-vitro permeability study. Biowaiver is a beneficial approach for getting approval of …

  Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 3, 2016 · pp. 22–30 Read article →