Автор: John Bloom and Richard A. Dean
Название: Biomarkers in Clinical Drug Development
Издательство: CRC Press
Год: 2003
ISBN: 9780824740269; 0824740262
Серия: Drugs and the Pharmaceutical Sciences (Book 132)
Язык: English
Формат: pdf
Размер: 11,9 mb
Страниц: 304

The term biomarker has the distinction of having become, within a few years of usage, both a euphemism so broadly used so as to limit its usefulness and a holy grail for drug hunters. A biomarker is, in the most general sense, an indicator of a normal or abnormal biological process. A clinical biomarker is a relatively new term for such indicators in humans, as applied to healthcare or disease management for individuals or populations, It is a convenient label for novel, or experimental, esoteric and established tests, or clinical assessments that range from a DNA sequence to a self-administered blood pressure measurement to the color of one’s eyes.

Biomarkers in Clinical Drug Development is an attempt to fill this void. The book approaches the subject from three perspectives: (1) biomarker applied science, (2) strategic applications, and (3) clinical operations. As is the case with most texts on applied science, there has been considerable progress in this field between the inception of this work, its execution, and publication. Most notable have been advances in biomarker discovery, including pharmacogenomics, proteomic applications, and molecular imaging; and regulatory guidance in areas such as cardiac and hepatic safety.