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Updated: Feb 9, 2026

Author Spotlight: Multi-Layered Approach to Understand Postnatal Functions of Pancreatic Islets in Non-Human Primates
Published on: November 8, 2024
Enhanced pre- and postnatal developmental toxicity (ePPND) study in non-human primates: Necessity, strategic
Jing Lu1, Dehu Dou2, Yawen Wang2
1TriApex Laboratories Co., Ltd, Nanjing, 211800, China; Nanjing Medical University, Nanjing, 211166, China.
Abstract:
Nonclinical developmental and reproductive toxicity (DART) studies are crucial components of novel drug development, as they identify reproductive and developmental risks and ensure drug safety in populations such as pregnant women and women of childbearing potential (WOCBP). Rodents or rabbits are commonly used in nonclinical studies to evaluate DART for chemical compounds. However, for most antibody-based biopharmaceuticals, non-human primates (NHPs) are the only pharmacologically relevant species, necessitating the use of NHPs in DART studies. These studies pose significant challenges due to stringent design requirements, complex protocols, prolonged timelines, and high costs. A single well-designed NHP study, in which the test substance is administered from gestational day 20 until delivery (enhanced Pre- and Postnatal Developmental study, ePPND study), is preferable to conducting separate Embryo-Fetal Developmental (EFD) and Pre- and Postnatal Developmental (PPND) studies. This review highlights the scientific rationale for NHP-based ePPND studies as mandated by major regulatory agencies, discusses advanced methodologies, key challenges (including endpoint selection, experimental design optimization, and data interpretation with case examples), and offers guidance for ePPND design across antibody-based therapeutics.
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