Nonclinical Safety Assessment for Small Molecules
![]() |
Nonclinical safety evaluation generally includes a characterization of toxic effects with respect to target organs, dose dependence, relationship to exposure and, when appropriate, potential reversibility. Nonclinical safety studies, although usually limited at the beginning of clinical development, should be adequate to characterize potential adverse effects that might occur under the conditions of the clinical trial to be supported.
|
![]() |