Open access peer-reviewed Edited Volume

Regulatory Validation of Biomarkers in Medicine

Tuba Gunel

Istanbul University


Types of biomarkers Molecular medicine Diagnosis Genomic approaches Validations for new biomarkers Omics Proteomic technologies Analytical platform Personalized Medicine Regulatory overview Food and Drug Administration

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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.

Publishing process

Book initiated and editor appointed

Date completed: August 1st 2019

Applications to edit the book are assessed and a suitable editor is selected, at which point the process begins.

Chapter proposals submitted and reviewed

Deadline Extended: Open for Submissions

Potential authors submit chapter proposals ready for review by the academic editor and our publishing review team.

Approved chapters written in full and submitted

Deadline for full chapters: October 21st 2019

Once approved by the academic editor and publishing review team, chapters are written and submitted according to pre-agreed parameters

Full chapters peer reviewed

Review results due: January 9th 2020

Full chapter manuscripts are screened for plagiarism and undergo a Main Editor Peer Review. Results are sent to authors within 30 days of submission, with suggestions for rounds of revisions.

Book compiled, published and promoted

Expected publication date: March 9th 2020

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About the editor

Tuba Gunel

Istanbul University

Dr. Gunel graduated in 1991 from the Department of Biology at the Istanbul University Faculty of Science, which she entered in 1987. She completed her master's degree in the Medical Genetics Program of Istanbul University, the Institute of Health Sciences in 1994 and her doctoral degree in Molecular Biology and Genetics in 2004. Dr. Gune received the title of associate professor in 2014. She is currently working as a lecturer in the Department of Molecular Biology and Genetics, Faculty of Science at Istanbul University. She mentors young scientists who want to do scientific studies in the field of Molecular Biology and Genetics for their master and Ph.D. studies so that they can continue their academic life. Dr. Gunel carries out researches on the early diagnosis of genetic problems especially related to pregnancy and women's health-diseases (ovarian cancer), better understanding of the molecular mechanisms of these diseases and reflection on the health of person-specific genetic changes in my research laboratory where she carries out her scientific studies. In addition to that, she has also been studying the sports genetics and genetic background of success on the sport, which has been very interesting in recent years. She has many articles and book chapters in the foreign language and Turkish, besides projects and early diagnosis of preeclampsia-related patents. She tries to learn and teach innovations by participating as an invited speaker in scientific platforms both in Turkey and abroad.

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Book chapters authored 2

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Introducing your Author Service Manager

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As an Author Service Manager my responsibilities include monitoring and facilitating all publishing activities for authors and editors. From chapter submission and review, to approval and revision, copyediting and design, until final publication, I work closely with authors and editors to ensure a simple and easy publishing process. I maintain constant and effective communication with authors, editors and reviewers, which allows for a level of personal support that enables contributors to fully commit and concentrate on the chapters they are writing, editing, or reviewing. I assist authors in the preparation of their full chapter submissions and track important deadlines and ensure they are met. I help to coordinate internal processes such as linguistic review, and monitor the technical aspects of the process. As an ASM I am also involved in the acquisition of editors. Whether that be identifying an exceptional author and proposing an editorship collaboration, or contacting researchers who would like the opportunity to work with IntechOpen, I establish and help manage author and editor acquisition and contact.

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