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Abstract
The translation of bench discoveries, be they devices or drugs, to clinical testing in humans can be a very long and expensive process and one with which the typical academic scientist is not familiar. A successful laboratory demonstration of a device or synthesis of a new imaging drug is very far indeed from being ready for human testing, and the path from early testing in humans to a marketed product is also long, more so for drugs than devices. The steps in translational research are diagrammed in Fig. 1.1 of the first chapter. Often the extent of translational research from the academic perspective is to obtain preliminary data in order to attract a commercial partner to finish the development and marketing. Before a drug or a device can even be tested in humans, much information must be collected on its chemical, physical, and biological characteristics. Formal applications to a variety of regulatory oversight entities will be required—such as IRBs, Radiation Safety Offices (RSOs), Radioactive Drug Research Committees (RDRCs), and various divisions of the FDA. See Table 4.1 for definitions of some of the many acronyms used in regulatory oversight. Beyond the seemingly formulaic requirements cited in guidance documents and by consultants, the actual information needed to permit early human studies must be informed by the science and the clinical purpose. Often traditional preclinical studies can be adjusted, delayed, or negotiated with justification that is supported by sufficient evidence.
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CHAPTER 4
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