Module 3 Presentations

07/05/2024

Late-stage Candidate  Limited characterization data before initially filed with regulatory agencies for the first clinical studies  Typical studies conducted whilst clinical trials are ongoing: Solids  Surface area  Particle size distribution  Polymorphism Solutions  Complexation constants  Aggregation constants  Detailed solution stability

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

17

Regulatory Dossier  Where is this information contained: S.1 General Information S.1.1 Nomenclature S.1.2 Structure S.1.3 General Properties

S.3 Characterization S.3.1 Elucidation of Structure and other Characteristics S.3.2 Impurities

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

18