EMA Outlines Generic Drugmaker Decisions for Setting Dissolution Specifications

August 22, 2017

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.

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