Magnetic Resonance Imaging in Pharmaceutical Safety Assessment

An imaging biomarker is an objective characteristic derived from an in vivo image which can indicate a normal biological process, pathogenic process, or a response to a therapeutic intervention. A quantitative imaging biomarker is measured on a ratio scale or interval scale, which makes them more suited to studies with follow-up after an intervention. Tissue properties such as tissue microstructure, composition, metabolism, function, and gross morphology can be assessed with quantitative imaging biomarkers. This chapter gives four examples of quantitative imaging biomarkers that can be applied in safety pharmacology studies: liver function, cardiac hypertrophy, hepatic steatosis, and brain microbleed assessment. Key advantages of the imaging approach include its noninvasive nature that allows follow-up of the same animal on several occasions, and the ability to translate the imaging biomarkers identified in preclinical safety assessment studies for use in clinical drug safety studies. Imaging technologies provide powerful insights into the biological effects of pharmaceuticals and can contribute important biomarkers that aid in the development of new therapies to treat disease.