Published 31 Aug 2017
Morphologically-Directed Raman Spectroscopy (MDRS)
GEN covers the role of MDRS in reducing the need for clinical bioequivalence endpoint studies Raman spectroscopy and MDRS enable determination of the size and shape of specific components within a multi-component blend. This article followed the recent…READ MORE >
Tags: ANDA, API, bioequivalence, FDA, MDRS