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The application of in vivo magnetic resonance (MR) in drug development has several requirements that differ significantly from most applications primarily because the biopharmaceutical industry must develop new safe and effective drugs more quickly and at lower cost in a highly regulated environment. In vivo MR is recognized as a useful method to provide biomarkers for target engagement, treatment response, safety and mechanism of action that can be translated between animal and clinical studies. Thus, it has the potential to help identify drugs that are more likely to be safe and effective earlier in the process of drug development, which may help reduce the time and money required to get new drugs to patients with an unmet medical need. A brief introduction of how novel drugs are discovered and developed, what drives the biopharmaceutical industry's interest in using biomarkers and what it takes to use MR as a biomarker to support drug development, including regulatory concerns, provides context for understanding what makes the application of in vivo MR in drug development different from most others. Exploration of three programs (trebananib, ZD6126 and axitinib) using dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) in the development of antivascular agents provides insight into how in vivo MR biomarkers impact drug discovery and development and the limitations of biomarkers.
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| http://dx.doi.org/10.1016/j.jmr.2018.04.012 | DOI Listing |
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