The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced the introduction of the NanoDis System for nanoparticle dissolution testing. Combining Agilent instrumentation ...

Viatris, which Pfizer created in 2020, voluntarily withdrew extended-release products made at a plant in Ireland after an ...

The dissolution profile of inhaled drugs underpins therapeutic efficacy and is an area of increasing regulatory scrutiny, particularly for the demonstration of bioequivalence in a generic. The new ...