There is an urgent need for predictive biomarkers in clinical research. Physicians, patients, and payers are demanding more efficacy and safety windows. Due to limited research funds, drug developers are forced to select projects they are confident in early in development to invest in expensive phase II & III studies to investigate further.
Although the need is clear, the most commonly used methods for quantification in serum or plasma samples are more than two decades old. These methods quantify the totality of proteins and overlook new developments and understanding of proteins as complex players that have multiple functions.
Separate quantification of individual protein components provides more information about protein formation, protein degradation, and potential signaling domains than a crude measurement of total protein. In fact, many chronic diseases such as osteoporosis, osteoarthritis, fibrosis of the liver, lung, kidney, skin, intestine and heart are due to an imbalance between tissue formation and degradation.
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