毒性研究:少年(NHP)
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可以在开发过程中使用早期研究来评估治疗的儿科安全性。少年NHP研究中的常见评估包括心血管,神经系统,呼吸道,胃肠道,肾和肝功能。