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 derived products, intended to treat patients with advanced cancer.  The recommendations describe the type and timing of preclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA).

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