Safer Medicines - putting patient safety first

Putting patient safety first

Human relevant assays vital for testing medicines

New paper by Dr Gerry Kenna published by Expert Opinion on Drug Metabolism & Toxicology:

"Human biology-based drug safety evaluation: scientific rationale, current status and future challenges"

Abbreviated abstract: Animal toxicity studies used to assess the safety of new candidate pharmaceuticals prior to their progression into human clinical trials are unable to assess the risk of non-pharmacologically mediated idiosyncratic adverse drug reactions (ADRs), the most frequent of which are drug-induced liver injury and cardiotoxicity...  The chemical insults can be detected using in vitro assays. These enable useful discrimination between drugs that cause high versus low levels of idiosyncratic ADR concern... Widespread acceptance and use of such assays has been hampered by the lack of correlation between idiosyncratic human ADR risk and toxicities observed in vivo in animals.

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