Module 3 2019

Points raised on pharmaceutical development Dissolution method and limits for control of dissolution in drug product specification

• Links to in-vivo performance

- Comparative data to support biowaivers

• Suitability for routine QC batch control - Discriminatory power • Suitability of limits - reflect performance of biobatch • Reflection paper on dissolution specifications (immediate release) - (EMA/CHMP/CVMP/QWP/336031/2017)

The Organisation for Professionals in Regulatory Affairs

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