A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product. Dissolution testing is an important tool for ...
Principles of dissolution testing, including method development and testing apparatus, are reviewed. Dissolution testing is an important tool for characterizing the performance of oral solid dosage ...
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 ...