All medical products pose risks and postmarketing surveillance is critical to expanding the limited evidence base that exists when new drug products are approved. Through initiation of the Sentinel Initiative (May 2008), the Food and Drug Administration (FDA) is...
The Australian TGA has adopted the EU Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3(R2)bb). The effective date was November 5, 2010. The purpose of this document is to...
Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010 View more presentations from TigerTox. Historical Overview During the past 30 years, genetic toxicology testing has evolved technologically to play an important safety assessment role in the...
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....
