By Kevin Kane, Global SME, Thermo Fisher Scientific
Drug sponsors face significant pressure to reduce the time required to move a new molecule through Phase I and into Phase II trials. If all goes well, identifying the quickest scale-up path for supplying efficacy trials and commercial demands is next. But at early stage, sponsors need to keep the formulation as simple as possible. This means identifying the desired critical quality attributes of a formulation and selecting only those must-have requirements that align closest to the objectives of each clinical trial stage.