Module 3 Presentations

07/05/2024

Compound Screening  Limited number of characterisations  Limited quantities of the compounds are available  Large number of compounds to test in a short period  e.g. chemical libraries in FBLD  Typical studies performed during early development:  Enantiomeric composition  Partition coefficients at selected pH  Estimated dissociation constant  Solubility at selected pH  Preliminary stability

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

15

Nonclinical/Clinical Candidate  Information required for the first clinical studies: Solids  Hygroscopicity  Preliminary polymorphism  Dissolution rate constants  Solid state stability Solutions  Partition coefficients as a function of pH  Solubility as a function of pH  Dissociation constant  Solubility in selected solvents  Modified solution stability  Also required for:  Understanding behavior under physiological conditions  Development of the formulation  Development of analytical methods

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

16