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ePPND and EFD NHP studies
Since the release of International Council for Harmonization of Technical Requirements (ICH) Guideline S6(R1) 2011 Pre- and Postnatal Development (PPND) and Embryo-Fetal Developmental (EFD) Toxicity Studies, it has been possible to perform both study types in a single study called enhanced Pre- and Postnatal Development (ePPND).
Especially for molecules where NHP models have been the only acceptable model, the ePPND study design has led to a greater reduction in research models. Furthermore, the new guideline also postponed the study performance into the late phase of clinical trials (Phase III), further reducing the number of nonclinical models needed since fewer molecules make it to this late stage in drug development.
Mainly large molecules (biopharmaceutically produced test articles such as antibodies or likewise) are the focus of NHP ePPND studies, due to their highly specific targets, which are found only in species closely related to humans.
