Module 3 Presentations

14/05/2024

The New Active Substance – dossier aspects

New vs. established Drug Substances – what changes from a module 3 viewpoint? • For a known chemical entity, quality standards are already established and are likely to be compendial – often CEP rather than ASMF / full 3.2.S • Physicochemical characteristics and stability of the drug substance is established

• Considerable published literature may be available The dataset for established drug substances is reduced when compared to the new active substance.

The Organisation for Professionals in Regulatory Affairs

17

Major deficiencies in the drug substance

The Organisation for Professionals in Regulatory Affairs

18

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