دانلود کتاب نشانگرهای زیستی در روانپزشکی اعصاب

 Although the term “biological marker” has been used since the late 1950s/early 1960s, it was only in the 1980s that the word “biomarker” started being widely used, especially in the context of chemicals considered dangerous in water, sedi

ments, and living organisms. After discussions on whether the term “biomarker” should be used only to describe any biological changes in response to exposure to xenobiotics, the increased knowledge about surrogate markers of clinical out

comes in the 1990s increased the appeal for the use of biomarkers in the context of any diseases.

As the field evolved, biomarkers have become the focus of interest of several interrelated disciplines (clinical trialists, statisticians, regulators, and therapeutic developers) and research applications. As a result, a variety of terms with overlap

ping meanings started being used, such as biological markers, biomarkers, surrogate markers, surrogate endpoints, intermediate endpoints, and others. To mitigate the ambiguity, an expert working group convened by the National Institutes of Health and the US Food and Drug Administration (FDA) published in 2001 a conceptual framework defining biomarker (or a biological marker) as “a characteristic that is objectively measured and evaluated as an indicator of a normal biological process, a pathological process, or a biological response to a therapeutic intervention”