Postnatal development studies

The Enhanced Pre- and Postnatal Development Study for Monoclonal Antibodies... 

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. 

Fritschy, J. M., Paysan, J., Enna, A., and Mohler, H. (1994) Switch in the expression of rat GABAA-receptor subtypes during postnatal development an immunohistochemical study. J. Neurosci. 14,5302-5324. 

Whether, in studies in animals, administration of the substance during the period of pre- or postnatal development induces nonheritable adverse effects in the progeny... 

Results from a number of animal studies indicate that exposure to levels of toluene that begin to produce maternal toxicity can cause fetal effects, including reduced fetal survival and retardation of growth and skeletal development toxicity. Rat studies also suggest that exposure in utero can impair behavioral development. Exposure to 2000 ppm 6 hours/day, for 80 days before mating and through lactation, produced no significant maternal toxicity but caused retardation of both fetal and postnatal development in rats. ... 

A developmental neurotoxicity study will provide information on the effects of repeated exposure to a substance during in utero and early postnatal development. 

Embryotoxicity (fetal examinations) and postnatal development assessed in the same study Three segment strategy (fertility, embryotoxicity, pre- and postnatal development)... 

Repeat-dose neurotoxicity studies may identify behavioral effects or impaired nerve functions that can interfere with mating or maternal care. Developmental neurotoxicity studies have been conducted for specific pesticide classes, following requirements of US-EPA. If such a study is available it can be examined not only for the study-specific endpoints on the developing brain but also compared to the prenatal toxicity study and the two-generation smdy with respect to general endpoints of pre- and postnatal development, respectively. 

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