Preclinical models are developed to test lead compounds for toxicity and efficacy. This report 1) explores novel preclinical models (in vivo, in vitro, in silico, and systems biology) that show promise to expedite and improve the target validation, lead...
The recent approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) of the 7 protein biomarker panel for use in detecting drug-induced kidney damage means that the biomarkers are now qualified at the same level by all of the ICH regulatory agencies....
The Federal Register and the ICH S9 Guidance for the nonclinical evaluation for anticancer pharmaceuticals issued today. The guidance provides recommendations for preclinical studies for the development of pharmaceuticals, including both drugs and biotechnology...
