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Books in Life sciences

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    • FDA's Drug Review Process and the Package Label

      • 1st Edition
      • December 1, 2017
      • Tom Brody
      • English
      • Paperback
        9 7 8 0 1 2 8 1 4 6 4 7 7
      • eBook
        9 7 8 0 1 2 8 1 4 6 4 8 4
      FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label.

    • Measurement and Analysis of Kinetic Isotope Effects

      • 1st Edition
      • Volume 596
      • September 12, 2017
      • English
      • Hardback
        9 7 8 0 1 2 8 1 2 2 7 3 0
      • eBook
        9 7 8 0 1 2 8 1 2 2 7 4 7
      Experimental Analysis of Enzyme Mechanism Using Isotope Effects, Volume 596, the latest release in the Methods in Enzymology series, continues the legacy of this premier serial with quality chapters authored by leaders in the field. Chapters in this comprehensive update include Measurement of enzyme binding isotope effects, Chemical ligation and isotope labeling to locate dynamic effects, Measurement of heavy enzyme isotope effects, Extracting kinetic isotope effects from a global analysis of reaction progress curves, KIE of metabolic flux and enzymes, Solvent and Primary KIE on Flavin Enzymes, and The Rapid Determination of Primary Deuterium Isotope Effects on Enzyme-Catalyzed Proton Transfer at Carbon in 50/50 HOH/DOD. Readers who are interested in applying or understanding this research will find useful methods currently used for measuring isotope effects on solution and enzyme reactions.

    • Intracranial Epidural Bleeding

      • 1st Edition
      • November 13, 2017
      • Jeremy Christopher Ganz
      • English
      • Paperback
        9 7 8 0 1 2 8 1 2 1 5 9 7
      • eBook
        9 7 8 0 1 2 8 1 2 2 3 9 6
      Intracranial Epidural Bleeding: History, Management, and Pathophysiology examines the history of the concepts underlying the understanding of the clinical features of epidural bleeding. The pathophysiology of epidural bleeding was examined in two PhD theses in the 1980s, with the results published in top international journals. However, these concepts have not been understood by the general neurosurgical community. This book provides a comprehensive overview of how epidural bleeding actually works. It can be used to help improve the interpretation of images during management, and to assess degrees of urgency. This book is written for neurosurgeons, neurologists, cerebrovascular physiologists, trauma surgeons, and medical historians.

    • Circuits, Signals, and Systems for Bioengineers

      • 3rd Edition
      • December 7, 2017
      • John Semmlow
      • English
      • Paperback
        9 7 8 0 1 2 8 0 9 3 9 5 5
      • eBook
        9 7 8 0 1 2 8 0 9 6 2 6 0
      Circuits, Signals and Systems for Bioengineers: A MATLAB-Based Introduction, Third Edition, guides the reader through the electrical engineering principles that can be applied to biological systems. It details the basic engineering concepts that underlie biomedical systems, medical devices, biocontrol and biomedical signal analysis, providing a solid foundation for students in important bioengineering concepts. Fully revised and updated to better meet the needs of instructors and students, the third edition introduces and develops concepts through computational methods that allow students to explore operations, such as correlations, convolution, the Fourier transform and the transfer function. New chapters have been added on image analysis, noise, stochastic processes and ergodicity, and new medical examples and applications are included throughout the text.

    • Approaches to Understanding Breast Cancer

      • 1st Edition
      • Volume 151
      • October 19, 2017
      • English
      • Hardback
        9 7 8 0 1 2 8 1 2 7 7 2 8
      • eBook
        9 7 8 0 1 2 8 1 2 7 7 3 5
      Approaches to Understanding Breast Cancer, Volume 151, the latest volume in the Progress in Molecular Biology and Translational Science series focuses on breast cancer, with new chapters that include information on Breast Cancer Epidemiology, Prevention, and Screening, DCIS: Current Principles of Management, Pregnancy and Hormonal Prevention of Breast Cancer, Chemokines: Key Players in Pathobiology of Breast Cancer, Mircrobiota and Breast Cancer, Experimental Therapeutic Use of Estrogen Receptor Beta Agonists in Prevention and Treatment of Endocrine Therapy Resistant Breast Cancers: Observations from Pre-Clinical Models, Targeting Breast Cancer Stem Cells: Key for Anti-Metastatic Therapy, and Experimental Therapy of Advanced Breast Cancer: Target NFAT1-MDM2-p53 Pathway.

    • Cheese

      • 4th Edition
      • May 10, 2017
      • Paul L.H. McSweeney + 2 more
      • English
      • eBook
        9 7 8 0 1 2 4 1 7 0 1 7 9
      Cheese: Chemistry, Physics and Microbiology, Fourth Edition, provides a comprehensive overview of the chemical, biochemical, microbiological, and physico-chemical aspects of cheese, taking the reader from rennet and acid coagulation of milk, to the role of cheese and related foods in addressing public health issues. The work addresses the science from the basic definition of cheese, to the diverse factors that affect the quality of cheese. Understanding these fermented milk-based food products is vital to a global audience, with the market for cheese continuing to increase even as new nutritional options are explored. Additional focus is provided on the specific aspects of the ten major variety cheese families as defined by the characteristic features of their ripening. The book provides over 1000 varieties of this globally popular food.

    • Imaging of Brain Concussion, An Issue of Neuroimaging Clinics of North America

      • 1st Edition
      • Volume 28-1
      • November 30, 2017
      • Roy Riascos + 1 more
      • English
      • Hardback
        9 7 8 0 3 2 3 5 6 9 9 0 3
      • eBook
        9 7 8 0 3 2 3 5 6 9 9 1 0
      This issue of Neuroimaging Clinics of North America focuses on Imaging of Brain Concussion, and is edited by Drs. Roy Riascos and Eliana E. Bonfante-Mejia. Articles will include: Traumatic Brain Injury: definition, neurosurgery, trauma-orthopedics, neuroimaging, and psychology-psychiatr... Multimodality advanced imaging for brain concussions; Perfusion weighted images in brain concussion; PET and SPECT in brain concussion; Imaging of chronic concussion; Imaging of concussion in young athletes; Imaging on concussion in blast injury; Conventional CT and MR in brain concussion; Structural imaging: structural MRI in concussion; Susceptibility weighted imaging and MR spectroscopy in concussion; Functional imaging fMRI – BOLD and resting state techniques in mTBI; Diffusion Weighted and Diffusion Tensor Imaging in mTBI; and more!

    • Advances in Agronomy

      • 1st Edition
      • Volume 143
      • April 18, 2017
      • English
      • Hardback
        9 7 8 0 1 2 8 1 2 4 2 1 5
      • eBook
        9 7 8 0 1 2 8 1 2 4 2 2 2
      Advances in Agronomy, Volume 143 continues to be recognized as a leading reference and first-rate source for the latest research in agronomy. This latest release brings new and updated information on Soil: The Forgotten Piece of the Water, Food, Energy Nexus, Humin: Its Composition and Importance in Soil Organic Matter, the Effects of Drought Stress on Morpho-Physiological Traits, Biochemical Characteristics, Yield and Yield Components in Different Ploidy Wheat: A Meta-Analysis, and a section on the Delineation of Soil Management Zones for Variable Rate Fertilization - A Review. Each volume in this series contains an eclectic group of reviews by leading scientists throughout the world. As always, the subjects covered are rich, varied, and exemplary of the abundant subject matter addressed by this long-running serial.

    • Nitric Oxide

      • 3rd Edition
      • July 24, 2017
      • Louis J. Ignarro + 1 more
      • English
      • Hardback
        9 7 8 0 1 2 8 0 4 2 7 3 1
      • eBook
        9 7 8 0 1 2 8 0 4 3 1 9 6
      Nitric Oxide: Biology and Pathobiology, Third Edition, provides information on nitric oxide, a signaling molecule of key importance for the cardiovascular system that regulates blood pressure and blood flow to different organs. With recent links to the role of nitric oxide in the expression of healthy benefits of controlled diet and aerobic exercise, and the reactions of nitric oxide that can impact cell signaling, this book provides a comprehensive resource during a time when increased research attention is being paid across the fields of pharmacology, biochemistry, cell and molecular biology, chemistry, immunology, neurobiology, immunology, nutrition sciences, drug development and the clinical management of both acute and chronic diseases.

    • Kidney Transplantation, Bioengineering, and Regeneration

      • 1st Edition
      • June 8, 2017
      • Giuseppe Orlando + 2 more
      • English
      • Hardback
        9 7 8 0 1 2 8 0 1 7 3 4 0
      • eBook
        9 7 8 0 1 2 8 0 1 8 3 6 1
      Kidney Transplantation, Bioengineering, and Regeneration: Kidney Transplantation in the Regenerative Medicine Era investigates how the field of regenerative medicine is changing the traditional premises of solid organ transplantation, specifically within the field of kidney transplantation. In Section 1, chapters illustrate the state of the art in kidney transplantation as well as the research behind the bioengineering and regeneration of kidney organoids for therapeutic renal replacement. In Section II, chapters catalog the technologies that are being developed and the methods that are being implemented to bioengineer or regenerate kidneys in order to restore function, while critically highlighting those technological advances which hold the most promise. The book thus encompasses clinical renal transplantation, tissue engineering, biomaterial sciences, stem cell biology, and developmental biology, as they are all applied to the kidney.

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