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A fully automated dissolution lab is an integrated, end to end architecture that enables reproducible testing, continuous throughput, and reliable data integrity. Understanding its building blocks, ...

Predicting Bioequivalence During Generic Drug Formulation. Small variations in formulation can affect bioequivalence. However ...

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 ...

As regulatory scrutiny tightens and cost pressures mount, laboratory leaders are redefining what a fully automated ...

Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry, as well as an experienced provider of validation and qualification services, ...

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 ...

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 ...