Adverse Events and Oncotargeted Kinase Inhibitors gathers and evaluates data on adverse events associated with tyrosine kinase inhibitors (TKIs), a powerful anti-tumor drug class that has recently been introduced for human therapy. This book compiles a comprehensive safety profile of each TKI from experiences in official therapeutic indications, also exploring off-label exploratory investigations and postmarketing pharmaceutical surveillance databases. A brief history of each drug's development and submission is provided, along with a more detailed analysis of the mechanism(s) of action involved in therapeutic activity or related to the insurgence of specific adverse events. Early chapters focus on general characteristics of TKIs, typology, and classification of adverse events, while the final chapters analyze TKIs as AE inducers and classes of AEs by system or organ involvement. This comprehensive resource compiles and critically reviews all of the relevant safety data for this class of drugs, with the goal of improving the understanding of pathogenesis and facilitating the prevention, monitoring, and management of these adverse events. - Offers a unique and comprehensive publication on the adverse events associated with a new and fast-growing class of medicines - Provides a systematic analysis of adverse events aimed at better prevention through understanding and offering insights for the development of safer drugs - Uses practical guidelines to establish a leading reference on this class of drugs for educators, researchers, drug developers, clinicians, safety professionals, and more

Tyrosine Kinase Inhibitors as Sensitizing Agents for Chemotherapy, the fourth volume in the Cancer Sensitizing Agents for Chemotherapy Series, focuses on strategic combination therapies that involve a variety of tyrosine kinase inhibitors working together to overcome multi-drug resistance in cancer cells. The book discusses several tyrosine kinase inhibitors that have been used as sensitizing agents, such as EGFR, BCR-ABL, ALK and BRAF. In each chapter, readers will find comprehensive knowledge on the inhibitor and its action, including its biochemical, genetic, and molecular mechanisms' emphases. This book is a valuable source for oncologists, cancer researchers and those interested in applying new sensitizing agents to their research in clinical practice and in trials. - Summarizes the sensitizing role of some tyrosine kinase inhibitors in existing research - Brings recent findings in several cancer types, both experimental and clinically, with a particular emphases on underlying biochemical, genetic, and molecular mechanisms - Provides an updated and comprehensive knowledge regarding the field of combinational cancer treatment

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. - Reveals strategies for winning FDA approval and for drafting the package label - Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases - This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug

Overexpression of receptor tyrosine kinases (RTKs) has been implicated in cancer. Increasing evidence suggests that dysregulation of RTKs is reported in many neurodegenerative and psychiatric disorders. Receptor Tyrosine Kinases in Neurodegenerative and Psychiatric Disorders provides a fundamental, pragmatic map of RTKs structure, activation, functions, mechanism of action, gene regulation, and signaling pathways in developing central nervous system (CNS), adult normal CNS, neurodegenerative and psychiatric disorders. Additionally, the structure, function, activation, and therapeutic potential of many growth factors have been covered. Here, international experts in the field offer a comprehensive discussion of results of pre-clinical and clinical studies of repositioning of anti-cancer receptor tyrosine kinase inhibitors (RTKIs) and other promising protein kinase inhibitors in various neurodegenerative disorders including, Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, Huntington's disease, and multiple sclerosis, and psychiatric disorders including, anxiety, depression, alcohol use disorder, and schizophrenia. In addition, the book discusses the obstacles and opportunities for the potential repositioning of kinase inhibitors in neurodegenerative and psychiatric disorders. Provides a thorough overview of RTKs biology and their role in health and disease progression and modulation Highlights RTK families and the numerous receptors within each subfamily Examines RTKIs and other protein kinase inhibitors in pre-clinical and clinical trials in both neurodegenerative and psychiatric disorders Gives future directions of possible safe effective targeted RTKIs and other protein kinase inhibitors that may be repositioned in various neurodegenerative and psychiatric disorders Includes chapter contributions from renowned experts in biology, pharmacology, neurology, psychiatry, and oncology

This book reviews current immunotherapeutic strategies for gastrointestinal (GI) malignancies, including immune composition, immune checkpoint inhibitors, cell therapy, and peptide vaccines used to protect against esophageal, gastric, hepato-biliary, pancreatic and colorectal cancers. It also discusses the current challenges of using immunotherapy for the treatment of gastrointestinal malignancies. The book reviews highly sensitive and specific immunomarkers for the detection of GI malignancies, and examines therapeutic vaccines and the major cytokines involved in GI immunotherapy, as well as their basic biology and clinical applications. In closing, the book explores various aspects of computational biology for the detection and treatment of GI malignancies.

This book covers every aspect of radiation myelopathy and considers the evidence from all species in which it has been studied. The historical and current understanding of the pathogenesis of this rare but devastating injury is first discussed. The evidence regarding the role of a variety of factors in radiation myelopathy is then reviewed. Readers will find detailed information on the impacts of total radiation dose, radiation volume, dose fractionation, hyper fractionation, age, anatomic level, comorbidities, radiation modifiers, other therapies, and retreatment of the spinal cord. Given the similarity of the pathogenesis of radiation myelopathy in humans and experimental animals, the potential for cross-species modelling of dose response is explored, with attention to relevant species differences. Treatment of the condition is also fully considered. New theories are presented regarding retreatment, small volume response, and the final step in white matter necrosis. The final chapter addresses the medicolegal issues elicited by radiation myelopathy, which is often the result of treatment error. Radiation Myelopathy will be of high value for radiation oncologists, radiation physicists, dosimetrists, biologists, neurologists, medical oncologists, and attorneys.

This manual gives step-by-step guidance on the evaluation and treatment of geriatric diseases and disorders. It covers incidence of disorders, diagnostic tests, associated diagnoses, clinical implications for mobility, and rehabilitation techniques. It offers a broad overview of the effects of aging on all body systems. Special geriatric considerations for laboratory assessment, thermoregulations, and pharmacology are also discussed. This manual is a resource for all training clinicians in geriatric care and is a quick-reference guide for students and practitioners in this field.