Quantitative MRI biomarkers supporting drug safety assessment, risk mitigation, and regulatory-ready evidence.
Most successful drug developments involve a careful balance between safety and efficacy. The FDA recognises the importance of biomarkers, including imaging biomarkers, in drug safety assessment. Imaging biomarkers of drug safety have played a major role in avoiding drug-induced harm to important organ systems, including liver, lung, brain, heart, and the musculoskeletal system.
Bioxydyn has deep expertise in the role of imaging biomarkers in drug safety and has contributed to multiple reviews and position papers. We played a leading role in the IMI/IHI-funded TRISTAN partnership for drug-induced interstitial lung disease and adverse liver transporter fluxes, focusing on cross-site standardisation and biological validation.
Drug developers must minimise the risk of false-positive readouts in clinical trials. Our attention to technical and biological validation, and our transparent VoxelFlow pipeline, helps clients avoid misleading safety signals.
Safety signals may occur sporadically and often without strong baselines, so safety studies require meticulous cross-site standardisation. Bioxydyn's imaging metrology ensures that biomarkers measured on one scanner are quantitatively comparable with measurements from other sites and vendors.
Bioxydyn's imaging biomarkers for lung toxicity are described in our Respiratory section and for liver in our Liver imaging section. Please contact us for advice on how best to deploy these tools as safety biomarkers.
Evidence base for imaging biomarkers in safety assessment, including transporter and toxicity studies.
Pharmaceutics 15(3)
Why it matters: Translational framework linking gadoxetate imaging with transporter-mediated DDI risk.
J Magn Reson Imaging 56(4):1042-1052