Imaging As A Biomarker To Optimize Drug Development

Imaging (e.g., x-ray) has been used in clinical practice for over a century, but mainly for diagnostic purposes. The value of imaging as a biomarker has been recognized only recently. In clinical development, the use of imaging must take into consideration the scope of clinical studies, which are usually multicenter and multinational (at least in confirmatory development), and there are restraints such as cost, effort and resources as well as the need to standardize techniques across centers to maximize the signal - to - noise ratio. The most common techniques used in clinical development include x-ray imaging, digi-talized imaging [including DEXA (dual energy x-ray absorptiometry)], computed tomography (CT) scans, nuclear imaging such as positron-emission tomography (PET) and single-photon-emission CT (SPECT), ultrasound, magnetic resonance imaging (MRI), spectrometry MR, and functional MR. Some of these tools are available only in specialized centers and are therefore adapted mainly for small studies during early development.

Imaging biomarkers can be used, for example, for the assessment of bioac-tivity (not only through change in anatomical shape but also through change in functional status), for the evaluation of the disposition of drugs, for the measurements of tissue concentrations of drugs, to characterize the number of receptors, for the binding efficiency and the receptor occupancy, and as a prognostic indicator as well as for assessment of molecular specificity.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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