New Paradigms in Drug Safety Testing
A new In the Spotlight highlights progress on several initiatives at the US Food & Drug Administration (FDA) where in vitro approaches are the basis of what they describe as “new paradigms” in drug safety testing.
The Comprehensive in vitro Proarrhythmia Assay (CiPA) consists of "a suite of mechanistically based in vitro assays coupled to in silico reconstructions of cellular cardiac electrophysiologic activity, with verification of completeness through comparison of predicted and observed responses in human-derived cardiac myocytes." CiPA is undergoing validation for the purpose of updating current regulatory requirements for the proarrhythmia assessment of human drugs, and will be the focus of a September 24 FDA webcast.
"Organ-on-chips" are another breakthrough technology being studied in FDA laboratories. Earlier this year, the FDA announced an agreement with Emulate to evaluate their human "organs-on–chips" technology. The first to be evaluated in FDA laboratories is the liver-chip, with the goal of determining how well the liver-chip can predict human liver toxicity for substances under the regulatory jurisdiction of the FDA such as drugs, cosmetics, and dietary supplements.
In summary, we discuss the potential role of FDA’s Drug Development Tools (DDT) Qualification Programs in facilitating the development and implementation of new in vitro tests as another approach to creating greater innovation and speed in new drug development. The current FDA DDT Qualification Programs include only biomarkers, clinical outcomes assessment, and animal models.
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