title: Drug-mediated toxicity: illuminating the 'bad' in the test tube by means of cellular assays?
abstract: Health problems are rising worldwide, be it as a consequence of lifestyle and longevity in increasingly affluent societies or due to a sharp rise in bacterial antibiotic resistance. The pharmaceutical industry is caught between high rates of attrition and the rather slow pace of a historically large regulatory system for pharmacological safety. Meanwhile, the past decade has seen a tremendous evolution of the biological toolbox, most notably of cellular assays, stem-cell differentiation and organ-mimicking systems. These systems were readily adapted for lead-compound identification. However, their use as toxicological test systems is lagging behind, not least because of a lack of regulatory acceptance. This review tries to elucidate the scale of the problem and discusses the applicability of the assays currently available, with particular regard to the use of stem cells.
authors.affiliation: German Federal Institute for Risk Assessment (BfR), Max-Dohrn-Strasse 8-10, Department of Product Safety, 10589 Berlin, Germany.
authors.forename: Tewes
authors.initials: T
authors.lastname: Tralau
authors.forename: Andreas
authors.initials: A
authors.lastname: Luch
mesh_terms: D000818:Animals; D001681:Biological Assay / Q000191:economics / Q000379:methods; D018929:Cell Culture Techniques / Q000379:methods; D002478:Cells, Cultured; D017277:Drug Approval / Q000191:economics; D004353:Drug Evaluation, Preclinical / Q000191:economics / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D051379:Mice; D023421:Models, Animal; D018675:Toxicity Tests / Q000379:methods*