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Biomarkers in Drug Development
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eigh...
Biomarkers in Drug Discovery and Development
This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development. Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated an...
Clinical Trials Handbook
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every...
The Role of the Study Director in Nonclinical Studies
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
Molecular Pathology Protocols
The era of molecular pathology has arrived. From its promising beg- nings in research laboratories, the field has grown, and continues to grow, to become a vital part of the care of an ever-increasing number of patients. Because of its recent emergence from the research taboratory, many molecuIar pathology protocols we still to be found in the primary litcramre, and have not appeared in a text. MO~PCU~Q~ Padhoiogy Protocob contains la- ratory protocoIs that have been developed by many of the authors for use in clinical molecular pathology laboratories and describe in detail Row to perform these assays. This book is therefore intended for clinical laboratory use by medical technologists and p...
Residue Reviews
Worldwide concern in scientific, industrial, and governmental com munities over traces of toxic chemicals in foodstuffs and in both abiotic and biotic environments has justified the present triumvirate of specialized publications in this field: comprehensive reviews, rapidly published progress reports, and archival documentations. These three publications are integrated and scheduled to provide in international communication the coherency essential for nonduplicative and current progress in a field as dynamic and complex as environmental contamination and toxicology. Until now there has been no journal or other publication series reserved exclusively for the diversified literature on "toxic"...
Molecular Pharmacology
This textbook provides a fresh, comprehensive and accessible introduction to the rapidly expanding field of molecular pharmacology. Adopting a drug target-based, rather than the traditional organ/system based, approach this innovative guide reflects the current advances and research trend towards molecular based drug design, derived from a detailed understanding of chemical responses in the body. Drugs are then tailored to fit a treatment profile, rather than the traditional method of ‘trial and error’ drug discovery which focuses on testing chemicals on animals or cell cultures and matching their effects to treatments. Providing an invaluable resource for advanced under-graduate and MSc...
Wildlife Review
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Targeted Biomarker Quantitation by LC-MS
The first book to offer a blueprint for overcoming the challenges to successfully quantifying biomarkers in living organisms The demand among scientists and clinicians for targeted quantitation experiments has experienced explosive growth in recent years. While there are a few books dedicated to bioanalysis and biomarkers in general, until now there were none devoted exclusively to addressing critical issues surrounding this area of intense research. Target Biomarker Quantitation by LC-MS provides a detailed blueprint for quantifying biomarkers in biological systems. It uses numerous real-world cases to exemplify key concepts, all of which were carefully selected and presented so as to allow...
