Module 3 2019

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 Characterisationof the Active Ingredient

The Organisation for Professionals in Regulatory Affairs