Do chronic studies in two species provide significant value in drug development?
Chronic studies in rodent (6 months) and non rodent (9 months) are required for approval of a new drug. Results of these studies are not required until the NDA is submitted, i.e. all the clinical trials are complete. The results of these studies are rarely included in the drug label. Since we generally have subchronic data in two species and long-term exposures in carcinogenicity studies, are the required chronic studies adding to patient safety?
Regulatory and Safety Evaluation