- Pharmaceutical formulation development is key to determining the optimal dosage form, composition and manufacturing route for a pharmaceutical product. Cost pressures are driving a need for more rapid drug development processes which include the selection of an effective formulation. Achieving a robust drug formulation by observing the principles of QbD enhances overall drug product performance and the resultant stability of complex dosage forms, whilst concurrently enabling less complex scale-up activities. In particular, Drug products can present unique formulation challenges when considering control of key quality attributes of in vitro and in vivo performance.