By Steve Jenkinson, VP Drug Discovery and Safety Assessment, Metrion Biosciences
Currently, only 10% of the drugs that enter Phase I receive marketing approval from the U.S. Food and Drug Administration (FDA), with unmanageable toxicity accounting for approximately 30% of the clinical failures for investigational new drugs (INDs). Safety-based discontinuation of INDs is mainly associated with cardiotoxicity (which is also one of the most common reasons for the withdrawal of marketed drugs).
The discontinuation and/or withdrawal of some of these drugs could have been predicted preclinically with more thorough safety screening, including validated Good Laboratory Practice (GLP) in vitro screening assays.
By performing GLP-compliant hERG assays, companies can speed the development of cardiovascular drugs by potentially replacing the need to run thorough QT studies.
Read the full article: Jenkinson, Steve Advanced In Vitro Screening of New Drugs for Proarrhythmic Activity, Genetic Engineering News. 2024 44:5, 48-50.
Find out about our GLP hERG screening services.
