CRED Getting the CMC Dossier Right 2024

28/08/2024

Drug Substance – Quality Attributes

Physico-chemical properties

● Defined by the characterisation of DS + needs of DP – pH – Melting point (range) – Solubility + permeability (NB: BCS classification/biowaivers) – Refractive index – Visicocity

Understanding physico-chemical properties informs development of correct formulation and delivery of the drug.

● Generally “direct” methods. No validation

The Organisation for Professionals in Regulatory Affairs

21

Drug Substance – Quality Attributes

Particle size

● For DP pharmaceutical forms that are solid/suspensions ● Will it impact; – Dissolution of DP (BCS/biowaiver) – DP processing/manufacture – DP content uniformity – Stability ● Decision tree from ICH Q6A very useful to define impact and guide development ● Control limits typically established based on clinical precedence but what of modelling the impact of PSD?

The Organisation for Professionals in Regulatory Affairs

22

11