Solution
Yes, combining fasting study and steady state study are possible especially for EU submission for modified release formulations. Combining two studies together saves time and cost and also provides added advantage of using same population, which further lowers the intra subject variability which helps in passing BE study. However, it is important to note that this approach should be carefully defined in the protocol with due consideration of sampling time point, blood loss, ethical and safety consideration. If you intend to discuss more detail please contact Pharmadesk confidently by clicking Book a Telecon. Pharmadesk has successfully combined and delivered fasting and steady state study together as well as combined two fasting or fed studies together intended to be submitted to two regulatory agency with single test and such products are already approved and are in market.
