Reproductive toxicity and teratogenicity

All reproductive studies entail ongoing administration of the proposed drug at three different dosage levels (ranging from non-toxic to slightly toxic) to different groups of the chosen target species (usually rodents). Fertility studies aim to assess the nature of any effect of the substance on male or female reproductive function. The drug is administered to males for at least 60 days (one full spermatogenesis cycle). Females are dosed for at least 14 days before they are mated. Specific tests carried out include assessment of male spermatogenesis and female follicular development, as well as fertilization, implantation and early foetal development.

These reproductive toxicity studies complement teratogenicity studies, which aim to assess whether the drug promotes any developmental abnormalities in the foetus. (A teratogen is any substance/agent that can induce foetal developmental abnormalities. Examples include alcohol, radiation and some viruses.) Daily doses of the drug are administered to pregnant females of at least two species (usually rats and rabbits). The animals are sacrificed close to term and a full autopsy on the mother and foetus ensues. Post-natal toxicity evaluation often forms an extension of such studies. This entails administration of the drug to females both during and after pregnancy, with assessment of mother and progeny not only during pregnancy, but also during the lactation period. Therapeutic proteins rarely display any signs of reproductive toxicity or teratogenicity.

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