Abstract
Clinical translations are a critical component for developing oral peptide dosage forms as an alternative to injections. This is particularly important given the variability between several preclinical species and the poor in vitro/in vivo correlations observed during the development of oral dosage forms. In addition to efficacy and safety, clinical studies provide statistical handles on the bioavailability and variability which are important to develop dosage forms. Several peptides have been advanced to the clinic in the last two decades but with limited success. In this chapter we review some of the early clinical studies of oral peptides ranging from insulin to the most recently approved semaglutide. We summarize clinical designs and success criteria outlined (where available) in these studies and highlight potential reasons for variability based on GI parameters between human subjects such as surface areas, transit time variations, and intestinal permeability. Futuristic considerations for oral peptide translational studies including digital technologies have been outlined as well.
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