ABSTRACT
This chapter is meant to be a basic guide for scientists who are responsible for contracting
juvenile animal toxicology studies to contract research organization (CRO) and need help
to understand the subject enough to be able to work with the CRO in designing the study,
reviewing study protocol, interpreting study results, and assessing potential risks in
children. Juvenile animal toxicology studies are highly specialized studies that require
experience and expertise in laboratories conducting these studies. It is very important that
juvenile animal toxicology studies should be contracted to a CRO that has considerable
experience in performing these studies, preferably one that has a lot of experience in
conducting developmental and reproductive toxicity studies. At the minimum, technicians
in the CRO should be proficient in handling and caring for young animals, and should have
sufficient experience in dosing young animals by the desired route of administration.
Ideally, the CRO should have had performed several validation studies in the juvenile
animals of interest to demonstrate their scientific and technical capabilities and to provide
appropriate historical background data.
