Recent regulatory changes and specific safety concerns now dictate a more thorough investigation for a range of drug classes that have the potential for use in children. These changes have resulted in an evaluation of the need and use of more routine supporting juvenile animal work to assess for potential functional (dynamic) and kinetic differences between neonates/infants and adults.
Juvenile studies require unique expertise due to the size of the subjects and corresponding dosing and handling considerations. Covance has the experience and expertise to design the most appropriate study to address specific indications and the age of the pediatric population, utilizing expertise from both our developmental and reproductive toxicology (DART) and general toxicology teams. Protocols are designed in accordance with the regulatory guidance set forth by the FDA and EMEA to meet regulatory submissions.