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 ...

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 ...

When you take a time-release drug, you count on it doing what the package says: release the drug slowly into your bloodstream to provide benefits over the specified period of time. When the drug ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...