AAPS Workshop Report on ICH M10

Booth, B; Vazvaei, F; Fluhler, E; Myler, H; Woolf, E

Vazvaei, F (reprint author), Merck & Co Inc, Dept Pharmacokinet Pharmacodynam & Drug Metab, West Point, PA 19486 USA.

AAPS JOURNAL, 2019; 22 (1):

Abstract

Over the last decade, several regulatory guidelines on bioanalytical method validation (BMV) have been issued by regulatory agencies around the world.......

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