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URL: http://c-path.org/programs/pstc/
Proper Citation: Predictive Safety Testing Consortium (RRID:SCR_003727)
Description: A public-private partnership to identify new and improved translational safety testing methods for use in nonclinical and clinical studies and submit them for formal regulatory qualification by the FDA (Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Japanese Pharmaceutical and Medical Devices Agency). The current 19 corporate members of the consortium share internal experience with nonclinical and clinical safety biomarkers in six working groups: cardiac hypertrophy, nephrotoxicity, hepatotoxicity, skeletal myopathy, testicular toxicity, and vascular injury. The ultimate goal of the consortium is to improve the current approach to drug safety testing and offer assurance to the drug developers that these approaches will be accepted by the regulatory authorities in their drug development programs. Through PSTC, members are able to share their expertise, resources, data, and internally developed approaches in a neutral, precompetitive, confidential environment. There are more than 250 participating scientists and C-Path serves as the trusted third party, leading the collaborative process by collecting and summarizing the data, and leading the interactions with global health authorities.
Abbreviations: PSTC
Resource Type: data or information resource, organization portal, portal, consortium
Keywords: drug, consortium, safety testing, safety, drug safety, clinical, nonclinical, biomarker, kidney, testicular, liver, skeletal muscle, vascular, drug development, biomarker assay
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