Juvenile toxicology testing

Testing guidelines for reproductive and developmental toxicity were established to evaluate the effects of exposure to a drug at any point in the life cycle; however, the exposure from birth to puberty was not directly covered in the guidelines. Administration of a drug to a neonate, infant, child, and/or young adult is different than to an adult because of the differences in prepubescent humans in absorption, distribution, metabolism, and excretion of drugs and the effects of a drug on an organ system that is undergoing maturation. The investigation of these differences involves adaptation of the principles used to test drugs for general and reproductive toxicity, safety pharmacology, and kinetics and adapting them to an appropriate species for testing. In addition, juvenile toxicity testing requires the understanding of the development of the organ system(s) of concern and being able to closely evaluate the overall growth and normal development including many times the effects on a second generation.