Phase-Appropriate Formulation Development – A Regulatory Perspective.

10 September 2018 11:35 - 12:10

As drug development moves from early phase to late phase, the DP formulation needs to continue to evolve to satisfy phase-appropriate regulatory requirements.  In the Small-Molecule space, the physico-chemical properties of the drug substance, BCS classification, the Quality Target Product Profile and speed-to-market are some of the key considerations in the decision-making process when developing phase-appropriate formulations.  The presentation will focus on these key considerations from the regulatory perspective.  A few relevant case studies will also be discussed.

Ambarish  Singh, Senior Director Regulatory CMC Strategist (small molecules) , Constellation Pharmaceuticals