Early phase know-how clears pathway to late stage success
Formulating a new candidate drug for first-in-human (FIH) trials must be considered carefully, as the decisions made can directly affect its chances of not only progressing to the next phase, but to achieving regulatory approval.
A number of factors need to be considered when planning and executing a FIH study, of which volunteer safety is always the primary concern.
Stability, for example, is not a large concern for FIH trials, however at later stages this becomes one of the most important factors. Therefore, an integrated approach to the formulation of a drug candidate for FIH trials will prove the most successful.
Torkel Gren, Senior Director, Science and Technology Officer at Recipharm, spoke to European Pharmaceutical Manufacturer to discuss the challenges involved with formulating a new drug candidate for FIH trials, and the effect these can have on whether it gains regulatory approval.
For the full article see here: https://www.epmmagazine.com/opinion/how-to-succeed-in/