FDA's Drug Review Process and the Package Label

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Author :
Publisher : Academic Press
ISBN 13 : 0128146486
Total Pages : 671 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis FDA's Drug Review Process and the Package Label by : Tom Brody

Download or read book FDA's Drug Review Process and the Package Label written by Tom Brody and published by Academic Press. This book was released on 2017-12-01 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Elsevier's 2022 Intravenous Medications - E-Book

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0323825168
Total Pages : 1408 pages
Book Rating : 4.3/5 (238 download)

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Book Synopsis Elsevier's 2022 Intravenous Medications - E-Book by : Shelly Rainforth Collins

Download or read book Elsevier's 2022 Intravenous Medications - E-Book written by Shelly Rainforth Collins and published by Elsevier Health Sciences. This book was released on 2021-04-16 with total page 1408 pages. Available in PDF, EPUB and Kindle. Book excerpt: Find the essential information you need to safely administer more than 400 intravenous drugs! For more than 45 years, Gahart’s Intravenous Medications: A Handbook for Nurses and Health Professionals has been a trusted resource for comprehensive drug coverage, unparalleled accuracy, and an intuitive quick-access format. In addition to updated drug interactions, precautions, alerts, and patient teaching instructions for all existing IV drugs, the 2022 edition includes approximately 10 new monographs of the most recent IV drugs to be approved by the FDA. Administering intravenous drugs is a critical task — inaccurate or out-of-date information is not an option. Known as the #1 IV drug handbook on the market, and with its history of impeccable accuracy, Gahart’s annual publication gives you the extra confidence and guidance you need to safely and effectively treat patients. Monographs on more than 400 IV drugs offer an impressive breadth of coverage that goes well beyond any comparable drug reference. Updated annual publication prevents you from referencing outdated information. Additional drug monographs are provided on the companion Evolve website. 45-year history of impeccable accuracy reinforces the importance of safe IV drug administration. Perfect depth of information equips you with everything that is needed for safe administration of IV drugs — nothing more, nothing less. Proven, clinically optimized format keeps all dosage information for each drug on either a single page or a two-page spread to prevent hand contamination by having to turn a page. Highlighted Black Box Warnings and relevant content make locating critical information fast and easy. Special circumstances in blue-screened text call attention to important circumstances that may not warrant Black Box Warnings. Life-stage dosage variances are highlighted for geriatric, pediatric, infant, and neonatal patients. Dilution and dosage charts within monographs provide quick access to essential clinical information. Convenient, alphabetical format organizes all drug monographs by generic name, allowing you to find any drug in seconds. NEW! Drug monographs for newly approved drugs by the FDA provide you with the most current drug information. Updates on drug interactions, precautions, alerts, and more have been made throughout the guide to reflect all changes to existing medications.

Applied Methods of Cost-effectiveness Analysis in Healthcare

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Author :
Publisher : Oxford University Press, USA
ISBN 13 : 0199227284
Total Pages : 326 pages
Book Rating : 4.1/5 (992 download)

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Book Synopsis Applied Methods of Cost-effectiveness Analysis in Healthcare by : Alastair Gray

Download or read book Applied Methods of Cost-effectiveness Analysis in Healthcare written by Alastair Gray and published by Oxford University Press, USA. This book was released on 2011 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the reader with a comprehensive set of instructions and examples of how to perform an economic evaluation of a health intervention, focusing solely on cost-effectiveness analysis in healthcare.

Drug Management of Prostate Cancer

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 160327829X
Total Pages : 421 pages
Book Rating : 4.6/5 (32 download)

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Book Synopsis Drug Management of Prostate Cancer by : William D. Figg

Download or read book Drug Management of Prostate Cancer written by William D. Figg and published by Springer Science & Business Media. This book was released on 2010-09-14 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prostate cancer is the most common noncutaneous prostate cancer. Research has revealed several distinct malignancy and the second leading cause of cancer mechanisms of castration-resistant disease that may deaths among men in the United States. It is a critical converge in patients with disease progression on public health problem and remains incurable in the ADT. Many approaches are currently being evaluated metastatic setting with mortality that usually occurs as to improve the treatment of this condition and these a result of castration-resistant disease. fndings have identifed several potential targets for Since Huggins and Hodges’ report of the dra- therapeutic intervention. These include drugs that are matic clinical effects of suppressing serum testos- more active or less toxic chemotherapy agents; drugs terone levels in men with advanced prostate cancer that induce androgen deprivation; drugs that target in 1941, hormone therapy (also called androgen the androgen receptor and/or androgen synthesis; deprivation therapy [ADT]) has become widely drugs that target specifc pathways, including ang- accepted as the mainstay of therapy for the treat- genesis and tyrosine kinase inhibitors, endothelin ment of advanced prostate cancer. ADT combined antagonists and matrix metalloproteinase inhibitors; with radiation therapy is a standard of care in the and immunologic approaches. Many of these agents treatment of men with locally advanced prostate seem promising and the rationale and effcacy of cancer on the basis of evidence that shows improved these emerging therapies remain to be validated in survival. The role of ADT in the management of future clinical trials.

Role of Nutraceuticals in Cancer Chemosensitization

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Author :
Publisher : Academic Press
ISBN 13 : 0128123745
Total Pages : 400 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Role of Nutraceuticals in Cancer Chemosensitization by :

Download or read book Role of Nutraceuticals in Cancer Chemosensitization written by and published by Academic Press. This book was released on 2017-10-18 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Role of Nutraceuticals in Chemoresistance to Cancer, Volume Two, focuses on nutraceuticals, the compounds derived from natural sources, which are usually multi-targeted as a means to overcome chemoresistance. This book discusses the role of several compounds related to nutraceuticals and chemoresistance, such as curcumin, resveratrol, indole 3-carbinol, tocotrienols, ursolic acid, fisetin, celastrol, gambogic, butein, catechins and silymarin. It is a valuable resource for cancer researchers, oncologists and members of several areas of the biomedical field who are interested in understanding how to use nutraceuticals as a sensitizing agent for chemotherapy. - Brings updated information on natural compounds used as specific inhibitors of cell signaling pathways as reviewed by experts in the field - Presents experts analysis and summary of reported and novel findings and potential translational application in cancer patients - Describes molecular mechanisms with new and helpful approaches for the readers to use in their own investigations

Chemotherapy and Immunotherapy in Urologic Oncology

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Author :
Publisher : Springer Nature
ISBN 13 : 3030520218
Total Pages : 303 pages
Book Rating : 4.0/5 (35 download)

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Book Synopsis Chemotherapy and Immunotherapy in Urologic Oncology by : Edouard J. Trabulsi

Download or read book Chemotherapy and Immunotherapy in Urologic Oncology written by Edouard J. Trabulsi and published by Springer Nature. This book was released on 2020-09-29 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is designed to familiarize clinical practitioners in systemic therapy options and medical management of urologic malignancies including prostate cancer, bladder and upper tract urothelial carcinoma, and renal cell carcinoma. Organized by organ system, the text highlights new therapies such as novel forms of androgen deprivation, cytotoxic chemotherapy, immune check point and immunomodulatory agents, and targeted therapies. Written by experts in the field, the book also reviews current chemotherapy and immunotherapy regimens for genitourinary malignancies and discusses indications, outcomes, and toxicities, as well as clinical trial concepts. Each of the book’s chapters offers a bulleted box of clinical pearls on the particular role of the APP. Chemotherapy and Immunotherapy in Urologic Oncology: A Guide for the Advanced Practice Provider is a resource for urologists, uro-radiologists, medical clinicians and family practitioners alike, familiarizing its audiences with systemic therapy regimens for urologic malignancies, as well as their expected outcomes and side effects.

Clinical Oncology

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Publisher :
ISBN 13 : 9780443075452
Total Pages : 0 pages
Book Rating : 4.0/5 (754 download)

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Book Synopsis Clinical Oncology by : Martin D. Abeloff

Download or read book Clinical Oncology written by Martin D. Abeloff and published by . This book was released on 2000 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: A must-have reference, this new edition provides practical information on treatment guidelines, details of diagnosis and therapy, and personal recommendations on patient management from experts in the field. Consistently formatted chapters allow for a user-friendly presentation for quick access of key information by the practicing clinician. Completely updated, this new edition includes all of the latest developments in treatment strategies of medical, surgical and radiation oncologists.

Fast Facts: Prostate Cancer

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Author :
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 1910797375
Total Pages : 138 pages
Book Rating : 4.9/5 (17 download)

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Book Synopsis Fast Facts: Prostate Cancer by : Roger S. Kirby

Download or read book Fast Facts: Prostate Cancer written by Roger S. Kirby and published by Karger Medical and Scientific Publishers. This book was released on 2017-03-08 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prostate cancer is unusual among solid tumors in that the majority of affected men die with, rather than of, the disease. This presents many challenges to healthcare professionals and patients in terms of deciding if, when and how to intervene in order to control tumor growth and spread, thereby extending survival but without compromising quality of life. This is the ninth edition of 'Fast Facts: Prostate Cancer' since 1996, testament to the rapid changes in the field and the steadily improving outlook for patients. This new edition provides many key updates: • the Gleason grade grouping, which has valuable prognostic value • nomograms to evaluate risk • our rapidly expanding understanding of the genetics and underlying pathogenesis of prostate cancer and the development of genomic tests to help identify those at greatest risk of developing clinically significant disease • the continuing debate about the role of PSA in the screening, detection and monitoring of prostate cancer • advances in imaging techniques, particularly multiparametric MRI, which is improving the accuracy of biopsy and reducing the numbers of negative biopsies • the roles of drugs, surgery and radiotherapy in the treatment of prostate cancer at different stages, and our ever-improving understanding of when and how best to intervene, aided by improving understanding of the risk factors for disease progression. Primarily intended for primary care providers, specialist nurses, junior doctors and allied healthcare professionals, this highly readable resource provides a comprehensive overview of prostate cancer, enabling fully informed discussions with patients about this complex disease. Contents: • Epidemiology and pathophysiology • Diet, lifestyle and chemoprevention • Screening and early detection • Diagnosis, staging and prognostic indicators • Management of clinically localized disease • Managing recurrence after initial therapy • Management of metastatic prostate cancer • Management of castrate-resistant prostate cancer • Survivorship and treatment complications

Drug Efflux Pumps in Cancer Resistance Pathways: From Molecular Recognition and Characterization to Possible Inhibition Strategies in Chemotherapy

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Author :
Publisher : Academic Press
ISBN 13 : 0128164344
Total Pages : 394 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Drug Efflux Pumps in Cancer Resistance Pathways: From Molecular Recognition and Characterization to Possible Inhibition Strategies in Chemotherapy by :

Download or read book Drug Efflux Pumps in Cancer Resistance Pathways: From Molecular Recognition and Characterization to Possible Inhibition Strategies in Chemotherapy written by and published by Academic Press. This book was released on 2019-11-27 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Efflux Pumps in Cancer Resistance Pathways: From Molecular Recognition and Characterization to Possible Inhibition Strategies in Chemotherapy, Volume Seven, describes the fundamental aspects of efflux pumps of the ATP-binding cassette superfamily in cancer resistance pathways, along with strategies to target and improve chemotherapy efficacy. Pumps of the ATP-binding cassette superfamily (ABCs) regulate the access of drugs to the intracellular space. In this context, the overexpression of ABCs is a well-known mechanism of multidrug resistance in cancer and is associated with therapeutic failure. Cancer types discussed include breast, endocrine, hematologic, gastrointestinal, musculoskeletal, lung, skin and central nervous system cancers. The book is a valuable source for researchers and advanced students in cancer, biology, pharmacology, pharmaceutical sciences, biomaterials and medical/clinical sciences that are interested in accessing a comprehensive compendium on efflux pumps in mechanisms of cancer resistance. Offers comprehensive and detailed descriptions of the basic aspects of efflux pumps in a very schematic and didactic manner Describes the involvement of efflux pumps in cancer resistance in different cancer types Encompasses an updated overview on state-of-the-art approaches that capitalize on their inhibition to improve chemotherapy and overcome resistance

Precision Medicine in Oncology

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1119432448
Total Pages : 288 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Precision Medicine in Oncology by : Bulent Aydogan

Download or read book Precision Medicine in Oncology written by Bulent Aydogan and published by John Wiley & Sons. This book was released on 2020-11-02 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: A FRESH EXAMINATION OF PRECISION MEDICINE'S INCREASINGLY PROMINENT ROLE IN THE FIELD OF ONCOLOGY Precision medicine takes into account each patient's specific characteristics and requirements to arrive at treatment plans that are optimized towards the best possible outcome. As the field of oncology continues to advance, this tailored approach is becoming more and more prevalent, channelling data on genomics, proteomics, metabolomics and other areas into new and innovative methods of practice. Precision Medicine in Oncology draws together the essential research driving the field forward, providing oncology clinicians and trainees alike with an illuminating overview of the technology and thinking behind the breakthroughs currently being made. Topics covered include: Biologically-guided radiation therapy Informatics for precision medicine Molecular imaging Biomarkers for treatment assessment Big data Nanoplatforms Casting a spotlight on this emerging knowledge base and its impact upon the management of tumors, Precision Medicine in Oncology opens up new possibilities and ways of working – not only for oncologists, but also for molecular biologists, radiologists, medical geneticists, and others.

Tumor Microenvironment

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Publisher : Springer Nature
ISBN 13 : 3030731197
Total Pages : 548 pages
Book Rating : 4.0/5 (37 download)

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Book Synopsis Tumor Microenvironment by : Alexander Birbrair

Download or read book Tumor Microenvironment written by Alexander Birbrair and published by Springer Nature. This book was released on 2021-10-18 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume discusses novel concepts in cancer biology, focusing on different factors that affect the tumor microenvironment. Topics covered include sex-based differences in the tumor microenironment, dormancy in the tumor microenvironment, the influence of obesity on the tumor microenvironment, and much more. Taken alongside its companion volumes, Tumor Microenvironment: Novel Concepts covers the latest research on various aspects of the tumor microenvironment, as well as future directions. Useful for introducing the newer generation of researchers to the history of how scientists studied the tumor microenvironment as well as how this knowledge is currently applied for cancer treatments, it will be essential reading for advanced cell biology and cancer biology students, as well as researchers seeking an update on research on the tumor microenvironment.

Hepatotoxicity

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Publisher : Lippincott Williams & Wilkins
ISBN 13 : 9780781719520
Total Pages : 850 pages
Book Rating : 4.7/5 (195 download)

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Book Synopsis Hepatotoxicity by : Hyman J. Zimmerman

Download or read book Hepatotoxicity written by Hyman J. Zimmerman and published by Lippincott Williams & Wilkins. This book was released on 1999 with total page 850 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by the foremost authority in the field, this volume is a comprehensive review of the multifaceted phenomenon of hepatotoxicity. Dr. Zimmerman examines the interface between chemicals and the liver; the latest research in experimental hepatotoxicology; the hepatotoxic risks of household, industrial, and environmental chemicals; and the adverse effects of drugs on the liver. This thoroughly revised, updated Second Edition features a greatly expanded section on the wide variety of drugs that can cause liver injury. For quick reference, an appendix lists these medications and their associated hepatic injuries. Also included are in-depth discussions of drug metabolism and factors affecting susceptibility to liver injury.

Analogue-based Drug Discovery III

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Publisher : John Wiley & Sons
ISBN 13 : 3527651101
Total Pages : 393 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Analogue-based Drug Discovery III by : János Fischer

Download or read book Analogue-based Drug Discovery III written by János Fischer and published by John Wiley & Sons. This book was released on 2012-10-15 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most drugs are analogue drugs. There are no general rules how a new drug can be discovered, nevertheless, there are some observations which help to find a new drug, and also an individual story of a drug discovery can initiate and help new discoveries. Volume III is a continuation of the successful book series with new examples of established and recently introduced drugs. The major part of the book is written by key inventors either as a case study or a study of an analogue class. With its wide range across a variety of therapeutic fields and chemical classes, this is of interest to virtually every researcher in drug discovery and pharmaceutical chemistry, and -- together with the previous volumes -- constitutes the first systematic approach to drug analogue development.

Lung Cancer: A Practical Approach to Evidence-Based Clinical Evaluation and Management

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0323496067
Total Pages : 275 pages
Book Rating : 4.3/5 (234 download)

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Book Synopsis Lung Cancer: A Practical Approach to Evidence-Based Clinical Evaluation and Management by : Lynn T. Tanoue

Download or read book Lung Cancer: A Practical Approach to Evidence-Based Clinical Evaluation and Management written by Lynn T. Tanoue and published by Elsevier Health Sciences. This book was released on 2018-05-30 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get a quick, expert overview of the many key facets of lung cancer evaluation and management with this concise, practical resource by Drs. Lynn T. Tanoue and Frank Detterbeck. This easy-to-read reference presents a summary of today's best evidence-based approaches to diagnosis and management in this critical area. - Covers diagnosis and evaluation, treatment considerations, and comprehensive care options for patients with lung cancer. - Provides insight on evidence for today's best practices, as well as future directions in the field. - Consolidates today's evidence-based information on the clinical aspects of lung cancer into one convenient resource.

Stereotactic Body Radiation Therapy

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Publisher : Springer Science & Business Media
ISBN 13 : 364225604X
Total Pages : 433 pages
Book Rating : 4.6/5 (422 download)

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Book Synopsis Stereotactic Body Radiation Therapy by : Simon S. Lo

Download or read book Stereotactic Body Radiation Therapy written by Simon S. Lo and published by Springer Science & Business Media. This book was released on 2012-08-28 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stereotactic body radiation therapy (SBRT) has emerged as an important innovative treatment for various primary and metastatic cancers. This book provides a comprehensive and up-to-date account of the physical/technological, biological, and clinical aspects of SBRT. It will serve as a detailed resource for this rapidly developing treatment modality. The organ sites covered include lung, liver, spine, pancreas, prostate, adrenal, head and neck, and female reproductive tract. Retrospective studies and prospective clinical trials on SBRT for various organ sites from around the world are examined, and toxicities and normal tissue constraints are discussed. This book features unique insights from world-renowned experts in SBRT from North America, Asia, and Europe. It will be necessary reading for radiation oncologists, radiation oncology residents and fellows, medical physicists, medical physics residents, medical oncologists, surgical oncologists, and cancer scientists.

Respiratory Endoscopy

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Author :
Publisher : Springer
ISBN 13 : 9812879161
Total Pages : 251 pages
Book Rating : 4.8/5 (128 download)

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Book Synopsis Respiratory Endoscopy by : Takehiro Izumo

Download or read book Respiratory Endoscopy written by Takehiro Izumo and published by Springer. This book was released on 2016-11-08 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a detailed overview of the latest innovations in respiratory endoscopy, from both diagnostic and therapeutic perspectives; each chapter focuses on one disease and the techniques for early diagnosis as well as treatment. It comprehensively covers treatment and procedures, including simultaneous X-ray fluoroscopy and its use during bronchoscopic procedures. This fast-developing technology is essential for the medical management of non-malignant and malignant diseases of the chest, especially lung cancer. Respiratory Endoscopy describes the cooperation between all the members of the healthcare team, and as such is a valuable resource not only for medical staff, but also for radiological technicians and nursing staff who contribute significantly in the care of the patients undergoing these invasive procedures. By promoting teamwork and providing practical know-how, it will improve the success and safety of respiratory endoscopy procedures.

Geriatric Oncology

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Author :
Publisher : Springer
ISBN 13 : 9783319574141
Total Pages : 1150 pages
Book Rating : 4.5/5 (741 download)

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Book Synopsis Geriatric Oncology by : Martine Extermann

Download or read book Geriatric Oncology written by Martine Extermann and published by Springer. This book was released on 2020-01-30 with total page 1150 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended as a comprehensive resource for clinicians and researchers seeking in-depth information on geriatric oncology. The coverage encompasses epidemiology, the biology and (patho)physiology of aging and cancer, geriatric assessment and management, hematologic malignancies, solid tumors, issues in patient care, and research methods. Since cancer is a disease of aging and people are living longer, most cancer patients are now aged 70 and older. Yet the more we age, the more diverse we become in terms of our health, biologic fitness, and cancer behavior. Typically, however, general oncology clinical trials address only a selected healthier and younger population of patients. Geriatric oncology is the area of oncology that addresses these issues but while a wealth of knowledge has been accumulated, information is often difficult to retrieve or insufficiently detailed. The SpringerReference program, in which this book is published, offers an ideal format for overcoming these limitations since it combines thorough coverage with access to living editions constantly updated chapter by chapter via a dynamic peer-review process, ensuring that information remains current and pertinent.