Adverse Events and Oncotargeted Kinase Inhibitors
Adverse Events and Oncotargeted Kinase Inhibitors

Author: Giuseppe Tridente

Publisher: Academic Press

Published: 2017-05-08

Total Pages: 738

ISBN-13: 0128094451

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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

Receptor Tyrosine Kinases in Neurodegenerative and Psychiatric Disorders
Receptor Tyrosine Kinases in Neurodegenerative and Psychiatric Disorders

Author: Heba Mohamed Mansour

Publisher: Elsevier

Published: 2023-06-06

Total Pages: 606

ISBN-13: 0443186782

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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

Protein Kinase Inhibitors as Sensitizing Agents for Chemotherapy
Protein Kinase Inhibitors as Sensitizing Agents for Chemotherapy

Author:

Publisher: Academic Press

Published: 2018-11-21

Total Pages: 294

ISBN-13: 0128127384

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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
FDA's Drug Review Process and the Package Label

Author: Tom Brody

Publisher: Academic Press

Published: 2017-12-01

Total Pages: 671

ISBN-13: 0128146486

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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

Translational Advances in Gynecologic Cancers
Translational Advances in Gynecologic Cancers

Author: Michael Birrer

Publisher: Academic Press

Published: 2017-01-25

Total Pages: 356

ISBN-13: 0128037989

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Translational Advances in Gynecologic Cancers straddles the bench and bed divide by highlighting important and interesting research that is translatable to the clinic. The contents of this book cover the entire spectrum, from promising laboratory based research, to clinical trial efforts. Further, new therapeutic indications based upon randomized phase III trials are also included. Clinicians will learn about lab-based science that is about to enter the clinic, along with the rationale behind translational endpoints in trials. Researchers will be able to identify and understand the clinical needs of patients with these types of tumors to improve their research focus. - Provides a comprehensive description of all evolving translational gynecologic cancer research for clinicians - Identifies knowledge gaps to inform the next research direction - Ties together clinical research and patient needs to help both the researcher and clinician - Addresses genomics, new target therapies, novel tools, and more for ovarian, endometrial, and cervical cancer

Immunotherapy for Gastrointestinal Malignancies
Immunotherapy for Gastrointestinal Malignancies

Author: Ramakrishna Vadde

Publisher: Springer Nature

Published: 2021-01-31

Total Pages: 257

ISBN-13: 9811564876

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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.

Companion and Complementary Diagnostics
Companion and Complementary Diagnostics

Author: Jan Trøst Jørgensen

Publisher: Academic Press

Published: 2019-05-08

Total Pages: 509

ISBN-13: 0128135409

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Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. - Covers all aspects, from biomarker discovery, to development and regulatory approval - Explains the "how to" aspects of companion diagnostics - Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

Radiation Myelopathy
Radiation Myelopathy

Author: Timothy Schultheiss

Publisher: Springer Nature

Published: 2022-08-01

Total Pages: 240

ISBN-13: 3030946584

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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.

Molecules to Medicine with mTOR
Molecules to Medicine with mTOR

Author: Kenneth Maiese

Publisher: Academic Press

Published: 2016-02-21

Total Pages: 474

ISBN-13: 012802755X

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Molecules to Medicine with mTOR: Translating Critical Pathways into Novel Therapeutic Strategies is a one-stop reference that thoroughly covers the mechanistic target of rapamycin (mTOR). mTOR, also known as the mammalian target of rapamycin, is a 289-kDa serine/threonine protein kinase that is ubiquitous throughout the body and has a critical role in gene transcription and protein formation, stem cell development, cell survival and senescence, aging, immunity, tissue regeneration and repair, metabolism, tumorigenesis, oxidative stress, and pathways of programmed cell death that include apoptosis and autophagy. Incorporating a translational medicine approach, this important reference highlights the basic cellular biology of mTOR pathways, presents the role of mTOR during normal physiologic function and disease, and illustrates how the mechanisms of mTOR can be targeted for current and future therapeutic treatment strategies. Coverage of mTOR signaling includes the entire life cycle of cells that impacts multiple systems of the body including those of nervous, cardiovascular, immune, musculoskeletal, endocrine, reproductive, renal, and respiratory origin. - Covers the role of mTOR by internationally recognized expert contributors in the field. - Provides a clear picture of the complexity of mTOR signaling as well as of the different approaches that could target this pathway at various levels. - Includes analysis of the role of mTOR and in both health and disease. - Serves as an important resource for a broad audience of healthcare providers, scientists, drug developers, and students in both clinical and research settings.

Molecular and Cellular Changes in the Cancer Cell
Molecular and Cellular Changes in the Cancer Cell

Author:

Publisher: Academic Press

Published: 2016-11-16

Total Pages: 618

ISBN-13: 0128096039

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Molecular and Cellular Changes in the Cancer Cell,the latest volume in the Progress in Molecular Biology and Translational Science series, includes a comprehensive summary of the evidence accumulated thus far on the molecular and cellular regulation of the various adaptations taking place in response to exercise. This volume examines some of the latest advances, highlighting some of the most important molecular and cellular alterations and environmental influences that collectively cause a normal cell to become cancerous. Special emphasis is given to changes that take place at the molecular and cellular level. Comprehensive and up-to-date survey of current knowledge on the cancer cell Includes the latest advances and the most important molecular and cellular alterations and environmental influences collectively causing cells to become cancerous Written by leading experts in the field