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Toxicology, Pathology, Anatomic Pathology, DART
Toxicity study: Juvenile (NHP)
Record Type: Study
Validation: GLP, Non-GLP
Models: NHP
Disease: Cardiology, CNS, Pulmonary Respiratory, Gastroenterology, Renal Hepatic
Juvenile toxicity studies can be an important component of drug development, especially for development processes where mature trials are insufficient.
Juvenile NHP studies are often required for experimental therapies in the U.S., EU and Japan. A new guideline (ICH S11 Step 4) recognized the importance of animal data in predicting the potential drug toxicity in children. These studies may be used late in the development process to assess the pediatric safety of a treatment. Common assessments within juvenile NHP studies include cardiovascular, nervous system, respiratory, gastrointestinal, renal and hepatic functions.
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