EMA Outlines Generic Drugmaker Decisions for Setting Dissolution Specifications

The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs.

The specification should be based on the quality characteristics of the batches used in bioavailability studies or clinical testing, the EMA said, adding that a similar approach could be used in developing innovator products.

The paper includes a decision tree for setting specifications based on dissolution over time. The EMA characterizes immediate release as at least 75 percent of the active substance being dissolved within 45 minutes.