How to Develop an Effective Formulation Strategy for Early Phase Human Studies
Ascendia CEO Jim Huang, Ph.D. published a Formulation Forum column in the September issue of Drug Development & Delivery that addresses how to develop a formulation strategy for early phase human studies. The column discusses three key points for consideration during selection of early phase formulations, as well as dosage form options for early phase clinical studies that will help speed time-to-market and control drug development costs.
Successful translation of discovery compounds into first-in-human (P1) and first-in-patient (P2) is a critical challenge facing the pharmaceutical industry writes Dr. Huang. To achieve these goals, a rational formulation development strategy is critical to avoid costly drug development failures, while expediting the development timeline in a cost-effective manner. This is particularly true for compounds with challenging properties in solubility and bioavailability.
A phase-appropriate formulation development process is important for successful translation of discovery compounds into P1 and P2. This approach should meet clinical requirements on the systemic exposure, dosing flexibility, clinical study design, and project timelines. Dr Huang also explains how Ascendia’s proprietary nano-technology platforms – AmorSol®, NanoSol®, and EmulSol® – address different compound challenges.
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