Drug developers need to get Phase 1 formulation development right. Without consistent Phase 1 materials, biopharma companies cannot gather reliable data that supports informed decisions about their drug candidates. Rising to that challenge requires extensive technical capabilities and highly experienced teams capable of coping with the time pressures and knowledge gaps inherent in Phase 1 formulation development, leading many biopharma companies to outsource the work. Phase 1, first-in-human clinical trials of New Chemical Entities are critical assessments of the safety of drug candidates. Through Single Ascending Dose and Multiple Ascending Dose studies, sponsors gain a vital early look at the viability of the safety profile of investigational medicinal products. None of that can happen without a formulation that can be consistently prepared and accurately dosed. Formulation scientists need to create such formulations so the sponsor can interpret clinical results and select the right dose for Phase 2 efficacy studies. Read our whitepaper for more details.
