BUSINESSJuvenile animal toxicity
Juvenile animal toxicity study as a nonclinical safety assessment for pediatric drug development evaluates the effects on growth and development, cognitive functions and motor activity, toxicokinetics and general toxicity following repeated dosing in juvenile animals. It can be tested on development of respiratory, nervous, immune, renal and reproductive systems depending on potential target organs.
Juvenile animal toxicity study can be conducted on drugs approved for use in the adult human population. Single or repeated dosing can be adopted depending on the test purpose. The dosing period can be established according to the application time in clinical trials and potential target organs. Also, the effects on toxicity of early stage can be predicted by Dose Range Finding Study.
- Oral and Intraperitoneal injections: from Postnatal Day 1
- Muscle and subcutaneous injections: from Postnatal Day 3 or 4
- Intravenous injection: from Postnatal Week 2 or 3
- Inferior vena cava: from Postnatal Day 0 to Day 21 /
Jugular vein: after Postnatal Day 21