Bioscience

Japanese regulators accept Critical Path’s biomarkers for drug toxicity tests

June 24, 2010

By Flinn Foundation

[Source: GenomeWeb News] – The Critical Path Institute today said that the Japanese Pharmaceuticals and Medical Devices Agency has accepted its seven-biomarker panel for use in detecting drug-induced kidney injury.

The acceptance, the first ever regulatory biomarker qualification decision by PMDA, means data generated using the panel can be submitted to the agency as part of the drug approval process in Japan, Critical Path said in a statement.

The biomarkers were developed by the Predictive Safety Testing Consortium, an initiative led by the Critical Path Institute that kicked off in 2006.

For more information: Japanese Regulators Accept Critical Path’s Biomarkers for Drug Toxicity Tests