Module 3 2019

P.2.2. Drug Product

• P.2.2.1 Formulation Development • Includes

• Description of clinical and market formulations • Formulation robustness

• Information from comparative in vitro studies (e.g., dissolution) or comparative in vivo studies (e.g., bioequivalence) that links clinical formulations to the proposed market formulation

The Organisation for Professionals in Regulatory Affairs