In 2004, the FDA has articulated a Critical Path Initiative to improve the efficiency of product development industry-wide, and brought attention to the pressing needs of defining new tools to better assess safety and effectiveness of new products. A better understanding of protein subtypes, protein degradation and other posttranslational modificarions (PTMs) is in complete alignment with this initiative. These aims can be addressed by systematic protein fingerprinting. The questions is whether the field of clinical chemistry is "up to the challenge". Can old assays based on yesterday's technologies answer the questions of tomorrow, with strong focus on the molecular action of treatments? Is a protein measurement simply a protein measurement?
November 1, 2011
Karsdal MA, Delvin E, Christiansen C
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