In the manufacture of solid dosage forms, the rate at which the active pharmaceutical ingredient (API) is dissolved into solvents simulating the digestive tract fluids is determined with dissolution ...

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 ...

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 ...