Zebrafish offer a nonclinical model for the high-throughput screening of drug compounds, including toxicity assessment, with resolution at the cellular level in living vertebrate organisms. These small, freshwater, tropical fish share genetic and biochemical...
Drug development is a complicated, often convoluted process. The ability to predict drug toxicity in humans from nonclinical data remains a major challenge. Since you can’t “erase” an adverse event, optimization of preclinical dose selection is...
Side effect overload on drug labels has less to do with true toxicity and drug safety than with manufacturer liability. Examination of more than 5600 drug labels yielded over half a million side effects. An average drug label and the more commonly prescribed drugs...
Biomarker use in translational medicine is predicated upon preclinical qualification and validation – 2 distinct steps in the biomarker development process. Prior to issue in 2009 (EMA) and 2010 (FDA, PMDA) of the renal-specific DRAFT qualification guidelines,...
Any new drug that penetrates the central nervous system must receive some preclinical analysis of abuse liability potential (Draft Guidance). Usually, it is determined through prior knowledge of chemistry and/or pharmacology of the candidate’s drug class that...
