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.
With over 25 years of experience in conducting nonclinical studies, you can rely on Altasciences for your program, and learn what preclinical criteria are needed to support your first-in-human clinical trials.
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.