Teva is voluntarily recalling a single lot of Anagrelide Capsules, USP 0.5mg, due to dissolution failure that was detected during a routine stability test. Teva is voluntarily recalling a single lot ...
WASHINGTON - More than 11,000 bottles of a prescription medication used to treat high blood pressure have been recalled ...
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 ...
Low-dose dissolution frequently demands reduced media volumes to keep early time-point concentrations above LOQ, and regulators may expect evaluation of higher-sensitivity analytics before lowering ...