About the book
Biomarkers are molecules that distinguish a normal physiological condition from a pathological condition or are created against therapeutic intervention. Biomarkers are biological molecules that are the sign of a normal or abnormal process or disease, found in blood, other body fluids or tissues (solid tumors, lymph nodes, bone marrow or circulating tumor cells). It is obligatory to test biomarkers specificity and sensitivity before clinical use. The validation approaches are commonly used for test biomarkers. For this reason, the regulatory authorities were required to inspect the accuracy of the validation process. In this book, biomarkers and their regulatory validation strategies are mainly considered. Firstly, the description of biomarkers and their role in medicine topics will be examined. Furthermore, genomic and proteomic strategies used for biomarker discoveries will be analyzed. As well, what is the importance of biomarkers and their validations in medicine? Obviously, their regulatory validation strategies and the authorities for this process will be indicated in this book.