Module 3 Presentations

14/05/2024

Points raised on pharmaceutical development Choice of excipients • Justification for preservative or antioxidant content (including over shelf-life) • Excipients of known effect (e.g. sorbitol, benzyl alcohol, ethanol, propylene glycol, azo dye colourants – think about target & special populations)

Questions to ask: • Is inclusion of the excipient absolutely necessary? • What are the risks versus the benefits of inclusion? • Are alternative products marketed that do not contain the excipient? • Could one excipient impact the biological effect of another? e.g. propylene glycol and ethanol in neonates

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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)

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