Biomarkers in Clinical Drug Development (Drugs and the Pharmaceutical Sciences)

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.

presenting Applications In Clinical Development, Pharmacokinetic/ Pharmacodynamic Modelling And Clinical Trial Simulation, This Reference Studies The Role Of Biomarkers In Successful Drug Formulation And Development.

doody Review Services

reviewer:aryeh Hurwitz, M.d.(university Of Kansas School Of Medicine)
description:this Book Discusses The Practicalities Of Implementing Studies Of Clinical Biomarkers In The Process Of Drug Development. Several Chapters Are Devoted To Validation, Statistical, And Regulatory Concerns.
purpose:its Purpose Is To Discuss The Application Of Biomarkers To Drug Development, Especially To Provide Informed Perspectives And Advice On The Unique Challenges Involved In Applying Biomarkers To Development, Registration, And Commercialization Of Pharmaceuticals In Today's Environment. While Such A Book Is Clearly Of Use, The Authors Have Not Been Entirely Successful In Achieving Their Goals. Several Of The Chapters Are Redundant. They Provide Practical Guidance In Collection, Processing,and Transport Of Clinical Specimens And In Handling Of Data. This Information Is Readily Available In Standard Texts Of Clinical Pathology And Chemistry.
audience:the Book Is Obviously Targeted To People Working In The Pharmaceutical Industry, Who Gather Data For New Drug Applications And Have To Contend With Regulatory Agencies.
features:some Of The Chapters Are Excellent. Those On Imaging Biomarkers And On Cardiac Repolarization Are Standouts. The Chapter On Quality Assurance And Regulatory Compliance Has A Valuable Glossary Of Terms And Abbreviations For The Uninitiated. Many Of The Other Chapters Are Too Short And Superficial To Be Self Sufficient. The Bibliographies Of Most Chapters Are Reasonably Current, Although Some Cite No References Past The Year 2000. What Is Lacking Is Any Meaningful Coverage Of Biomarkers For Common Clinical Conditions, Such As Cardiovascular, Neurodegenerative, Malignant, Rheumatologic, Psychiatric, And Other Diseases. In Such Conditions, Which Commonly Take Decades To Develop, It Would Be Useful To Present And Evaluate Availability And Validity Of Biomarkers For Identifying Susceptible Patients And For Following Courses Of Their Diseases And Responses To Drug Therapy.
assessment:this Is An Uneven Book. Some Chapters Are Well Written, Complete, Current, And Comprehensive Enough To Stand Alone. Others Are Superficial, Trivial, And Laden With Jargon. At A Rather High Price It Is Not A Particularly Good Buy. Other Recent Books, Such As biomarkers Of Disease: An Evidence-based Approach, Edited By Trull Et Al. (cambridge University Press, 2002), And biomarkers And Surrogate Endpoints: Clinical Research And Applications, Edited By Downing (elsevier, 2000), Are Better.

Presenting recent applications in clinical development, pharmacokinetic/ pharmacodynamic modeling, and clinical trial simulation, this in-depth reference studies the role of biomarkers in successful drug formulation and development--utilizing the latest discoveries in biomarker science to determine the safety and efficacy of emerging drug compounds