Postnatal development studies nonhuman primates

For most biotherapeutics that do not cross-react with rodents or rabbits, an embryofetal development study in macaques is generally conducted during clinical development to support the inclusion of women of childbearing potential in clinical trials. However, postnatal development studies in nonhuman primates have not routinely been conducted. Consequently, the protocols and the end points are less well established for evaluation of postnatal effects on the immune system. 

At the time of birth, macaques and humans have a fuUy developed immune system. This contrasts with rodents that have an immature immune system at the time of birth (Holladay and Smialowicz, 2000). This difference alone does not predude the use of the rodent in developmental toxicity studies, so long as there is adequate species cross-reactivity of the test agent and the animals are dosed appropriately during critical periods in immune system development. Because a considerable amount of extrauterine immune system development occurs in the mouse versus the human or nonhuman primate, it may be necessary to dose the rodent pups during the postnatal period in order to mimic the human situation. This is not necessary for nonhuman primates where intrauterine immune system development mimics the human situation. 

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