In contrast to its decision in Nuvo Pharmaceuticals, Inc. v. Dr. Reddy’s Laboratories Inc., which seemed to impose a higher standard for satisfying the written description requirement, the Federal ...

Industry, equipment vendors, and regulators are busy refining the precision and reliability of dissolution testing. Solid dosage formulators rely on dissolution testing to mechanically model the ...

The pharmaceutical industry?s increasing interest in inhaled drugs has prompted several researchers to propose standard dissolution-testing methods for these products. For decades, pharmaceutical ...

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 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 ...

In addition to use of dissolution testers, this three-day course will also cover equipment qualification, development and validation of dissolution procedures, and the use of dissolution testing in ...

Dissolution and drug release tests are directly relevant to the safety and efficacy of many common pharmaceutical dosage forms. To achieve reliable and reproducible results, analysts must understand ...