Current Practices in the Preclinical Safety Assessment of Peptides

Abstract There has been an explosion of peptides in drug development and there are currently dozens of marketed therapeutic peptides. The road map for developing peptides is by association to existing biopharmaceutical and/or new chemical entity guidance documents rather than a guidance that is specific for peptides. This article reviews the preclinical development experience across therapeutic peptides, highlighting what has gone before and some considerations for the future.