Module 3 2019

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 Characterisationof the Active Ingredient

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