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BUSINESSReproductive & Developmental Studies

Introduction

The aim of reproductive and developmental toxicity studies is to ascertain the effects of drugs, chemicals, or agricultural chemicals on the reproductive system. These studies examine the effects of substances on the reproductive system in all stages, including gamete development, fertilization, pregnancy, labor, and nursing, as well as examining fetal development and teratogenicity.

While there are slight differences in the application of standards (ICH, OECD, MHW, KFDA), in the main there are two options available: a standard test and a hybrid test. In addition, Biotoxtech, Ltd. designs and conducts studies suitable to the aims of and in discussion with the sponsor.

Our Studies (Applicable to ICH, OECD, JMHW, MFDS, NIER, RDA))

Rodents (generally rats) are used to test for toxic effects of the test substance from pre-mating, to mating, to implantation. Females are examined for effects on menstruation, fertilization, implantation, and early fetal development. Males are examined for spermatogenesis, sexual drive, and sperm maturation (semen).

Fetal Development Study (Segment II)

The test substance is administered to rodents (generally rats) and non-rodents (generally rabbits) from embryo development to the closure of the palate. This study evaluates the effects on the maternal parent animal, and on the embryo, and on the embryo and embryo development as well as teratogenicity.

Pre- and Post-natal Development, and Maternal Function Study (Segment III)

The test substance is administered to female rodents (generally rats) from the stage of implantation to lactation, in order to examine the effects on pregnancy and lactation, and the growth and development of the fetus. The reproductive functions of the offspring are examined in order to ascertain the presence of delayed toxicity.