Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
|Articles|September 9, 2013
FDA Issues Guidance on Bioequivalence
Author(s)BioPharm International Editors
Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.
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FDA has published
The guidance recommends single actuation content, aerodynamic particle size distribution in-vitro, and the fasting pharmacokinetic (PK) BE studies for all strengths of the T and R products. Clinical endpoint study is recommended for the lowest strength of the T and R products.
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