Significance of Prenatally or Early Postnatally-Induced Organ Dysfunctions — Other than CNS Defects
Within the framework of registration of medicinal products extensive studies for reproductive toxicity are required to identify possible hazards. However, the routinely conducted studies on fertility, embryo/fetotoxicity — including teratogenicity — and postnatal manifestations of prenatally induced lesions are not always sufficient to detect the toxic potential of chemical substances on reproductive and developmental functions. Furthermore, the induction of adverse effects is not confined to the prenatal period, and the newborn and infant may be more vulnerable to a given chemical than the adult organism. Consequently, such hazards are not recognized and therefore potential risks cannot be fully assessed. In this paper we will discuss three examples to elucidate that, e.g., “functional anomalies” are not detected with the administratively required and routinely performed tests.
KeywordsToxicity Urea Gentamicin Nucleoside Nephritis
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