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Glossary
Pages 87-90

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From page 87...
... Information may come from many sources, including patient statistics, tissue specimens, genetics research, and clinical trials. Biomarker -- a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.
From page 88...
... -- "An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modification in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy" (Department of Health and Human Services IRB Guidebook)
From page 89...
... Preclinical studies usually take place before clinical trials in humans are conducted. Precompetitive collaboration -- collaboration among competitors to achieve goals that can be more effectively accomplished by a group effort and have the potential to benefit everyone.
From page 90...
... -- a monoclonal antibody that binds to HER2 (human epidermal growth factor receptor 2) , and can kill HER2positive cancer cells.


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