Cabazitaxel In Patients With Castration Resistant Prostate Cancer

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FDA's Drug Review Process and the Package Label

Author : Tom Brody
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

Cancer Chemotherapeutic Agents

Author : William O. Foye
Publisher :
ISBN 13 :
Total Pages : 734 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Cancer Chemotherapeutic Agents by : William O. Foye

Download or read book Cancer Chemotherapeutic Agents written by William O. Foye and published by . This book was released on 1995 with total page 734 pages. Available in PDF, EPUB and Kindle. Book excerpt: An authoritative treatment of the discovery, development, and understanding of cancer chemotherapeutic agents. Addresses the major classes of chemotherapeutic agents, including antimetabolites, agents that react with DNA, inhibitors of transcription enzymes, topoisomerase inhibitors, DNA minor-groove binding compounds, antimotic agents, bleomycin group antitumor antibiotics, antihormones, paclitaxels, and photochemically activated agents. Provides an overview of the various classes of agents now considered important. Examines a method for determining the similarity of mechanism of the compounds in a given class.

Elsevier's 2022 Intravenous Medications - E-Book

Author : Shelly Rainforth Collins
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

Author : Alastair Gray
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.

Evidence-based Urology

Author : Philipp Dahm
Publisher : John Wiley & Sons
ISBN 13 : 1119129885
Total Pages : 614 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Evidence-based Urology by : Philipp Dahm

Download or read book Evidence-based Urology written by Philipp Dahm and published by John Wiley & Sons. This book was released on 2018-09-24 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt: An updated and revised resource to evidence-based urology information and a guide for clinical practice The revised and updated second edition of Evidence-Based Urology offers the most current information on the suitability of both medical and surgical treatment options for a broad spectrum of urological conditions based on the best evidence available. The text covers each of the main urologic areas in specific sections such as general urology, oncology, female urology, trauma/reconstruction, pediatric urology, etc. All the evidence presented is rated for quality using the respected GRADE framework. Throughout the text, the authors highlight the most patient-important, clinical questions likely to be encountered by urologists in day-to-day practice. A key title in the “Evidence-Based” series, this revised and expanded edition of Evidence-Based Urology contains new chapters on a variety of topics including: quality improvement, seminoma, nonseminomatous germ cell tumor, penile cancer, medical prophylaxis, vesicoureteral reflux disease, cryptorchidism, prenatal hydronephrosis, and myelodysplasia. This updated resource: Offers a guide that centers on 100% evidence approach to medical and surgical approaches Provides practical recommendations for the care of individual patients Includes nine new chapters on the most recently trending topics Contains information for effective patient management regimes that are supported by evidence Puts the focus on the most important patient and clinical questions that are commonly encountered in day-to-day practice Written for urologists of all levels of practice, Evidence-Based Urology offers an invaluable treasure-trove of evidence-based information that is distilled into guidance for clinical practice.

Hepatotoxicity

Author : Hyman J. Zimmerman
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.

Drug Management of Prostate Cancer

Author : William D. Figg
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.

Precision Molecular Pathology of Prostate Cancer

Author : Brian D. Robinson
Publisher : Springer
ISBN 13 : 3319640968
Total Pages : 564 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis Precision Molecular Pathology of Prostate Cancer by : Brian D. Robinson

Download or read book Precision Molecular Pathology of Prostate Cancer written by Brian D. Robinson and published by Springer. This book was released on 2018-02-13 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume focuses on our current understanding of the molecular underpinnings of prostate cancer and their potential application for precision medicine approaches. The emergence and applications of new technologies has allowed for a rapid expansion of our understanding of the molecular basis of prostate cancer and has revealed a remarkable genetic heterogeneity that may underlie the clinically variable behavior of the disease. The book consists of five sections which provide insight about the following: (1) General principles; (2) Molecular signatures of primary prostate cancer; (3) Molecular signatures of advanced prostate cancer; (4) Key molecular pathways in prostate cancer development and progression; (5) and Precision medicine approach: Diagnosis, treatment, prognosis. Precision Molecular Pathology of Prostate Cancer is an important resource for the practicing oncologist, urologist, and pathologist, and will also be useful for researchers in the prostate cancer community.

Surgical Management of Advanced Pelvic Cancer

Author : Desmond C. Winter
Publisher : John Wiley & Sons
ISBN 13 : 1119518407
Total Pages : 324 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Surgical Management of Advanced Pelvic Cancer by : Desmond C. Winter

Download or read book Surgical Management of Advanced Pelvic Cancer written by Desmond C. Winter and published by John Wiley & Sons. This book was released on 2021-11-01 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: An innovative guide to the practice of pelvic exenterative surgery for the management of advanced pelvic neoplasms Exenterative surgery plays an important role in the management of advanced pelvic cancer. However, while a large body of evidence regarding outcomes following pelvic exenteration now exists, practical strategies and management options remain unclear. Surgical Management of Advanced Pelvic Cancer addresses this problem by assembling world-leaders in the field to provide insights into the latest techniques and best practices. It includes detailed coverage of: Surgical anatomy Operative approaches and exenterative techniques Reconstruction options Current evidence on survival and quality of life outcomes Featuring essential information for those managing patients with advanced pelvic neoplasms, Surgical Management of Advanced Pelvic Cancer consolidates the latest data and practical advice in one indispensable guide.

Nanostructures for Cancer Therapy

Author : Alexandru Mihai Grumezescu
Publisher : Elsevier
ISBN 13 : 0323461506
Total Pages : 922 pages
Book Rating : 4.3/5 (234 download)

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Book Synopsis Nanostructures for Cancer Therapy by : Alexandru Mihai Grumezescu

Download or read book Nanostructures for Cancer Therapy written by Alexandru Mihai Grumezescu and published by Elsevier. This book was released on 2017-04-11 with total page 922 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nanostructures for Cancer Therapy discusses the available preclinical and clinical nanoparticle technology platforms and their impact on cancer therapy, including current trends and developments in the use of nanostructured materials in chemotherapy and chemotherapeutics. In particular, coverage is given to the applications of gold nanoparticles and quantum dots in cancer therapies. In addition to the multifunctional nanomaterials involved in the treatment of cancer, other topics covered include nanocomposites that can target tumoral cells and the release of antitumoral therapeutic agents. The book is an up-to-date overview that covers the inorganic and organic nanostructures involved in the diagnostics and treatment of cancer. - Provides an examination of nanoparticle delivery systems for cancer treatment, illustrating how the use of nanotechnology can help provide more effective chemotherapeutic treatments - Examines, in detail, the different types of nanomaterials used in cancer therapy, also explaining the effect of each - Provides a cogent overview of recent developments in the use of nanostructured materials in chemotherapeutics, allowing readers to quickly familiarize themselves with this area

Blandy's Urology

Author : Omar M. Aboumarzouk
Publisher : John Wiley & Sons
ISBN 13 : 1118863372
Total Pages : 884 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Blandy's Urology by : Omar M. Aboumarzouk

Download or read book Blandy's Urology written by Omar M. Aboumarzouk and published by John Wiley & Sons. This book was released on 2019-05-06 with total page 884 pages. Available in PDF, EPUB and Kindle. Book excerpt: Die 3. Auflage von Blandy?s Urology ist auf dem besten Weg, ein Klassiker zu werden. Die neueste Auflage eines der populärsten Fachbücher der Urologie vereint erfolgreich alles Wissenswerte zur allgemeinen Urologie und Chirurgie in der Urologie für die Zielgruppe der Urologen und Chirurgen. Hauptmerkmal ist die einzigartige Art und Weise von Blandy, urologische Erkrankungen und deren Management zu beschreiben: - Klare, direkte und unkomplizierte Beschreibungen von Krankheiten und Störungen mit Hunderten klinischer Fotos. - Eine Fülle exzellenter Schaubilder zu chirurgischen Eingriffen, die die besten Operationstechniken verdeutlichen. - Legt den Nachdruck auf die häufigsten Erkrankungen in der klinischen Praxis. - Jedes Thema ist einem anatomischen Bereich zugeordnet. Ein Fachbuch, das wegen seines direkten Zugangs zu dem Fachgebiet vor allem von Urologen und angehenden Chirurgen geschätzt wird. Eignet sich auch für die Prüfungsvorbereitung und als Auffrischung

PET/CT in Prostate Cancer

Author : Gary Cook
Publisher : Springer
ISBN 13 : 3319576240
Total Pages : 73 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis PET/CT in Prostate Cancer by : Gary Cook

Download or read book PET/CT in Prostate Cancer written by Gary Cook and published by Springer. This book was released on 2017-07-24 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt: This pocket book explains the significant and well-documented impact that PET/CT can have on the management of prostate cancer through the provision of high-quality evidence regarding function and structure. Up-to-date information is supplied on the relevance of PET/CT to diagnosis, treatment planning, and therapy, including the emerging role of PET/CT with PSMA. Readers will also find clear explanation of the relation of the clinical and pathological background to imaging and the value of PET/CT compared with conventional radiological imaging. The book will be an excellent asset for referring clinicians, nuclear medicine/radiology physicians, radiographers/technologists, and nurses who routinely work in nuclear medicine and participate in multidisciplinary meetings. It is published within the Springer series Clinicians’ Guides to Radionuclide Hybrid Imaging, which presents contributions from professionals worldwide who share a common purpose in promoting nuclear medicine as an important imaging specialty for the diagnosis and management of oncological and non-oncological conditions.

Molecular Biology of Prostate Cancer

Author : Manfred Wirth
Publisher : Walter de Gruyter
ISBN 13 : 3110807270
Total Pages : 220 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Molecular Biology of Prostate Cancer by : Manfred Wirth

Download or read book Molecular Biology of Prostate Cancer written by Manfred Wirth and published by Walter de Gruyter. This book was released on 2013-05-22 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Fast Facts: Prostate Cancer

Author : Roger S. Kirby
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

Cancer Clinical Trials

Author : Tomasz M. Beer
Publisher : Diamedica
ISBN 13 : 9780982321973
Total Pages : 0 pages
Book Rating : 4.3/5 (219 download)

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Book Synopsis Cancer Clinical Trials by : Tomasz M. Beer

Download or read book Cancer Clinical Trials written by Tomasz M. Beer and published by Diamedica. This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: A readable guide for anyone who is considering therapeutic options in addition to standard cancer therapy. The book seeks to share knowledge about cancer clinical trials with people living with cancer, their families and loved ones.

Urologic Oncology

Author : Axel S. Merseburger
Publisher : Springer
ISBN 13 : 9783319426228
Total Pages : 870 pages
Book Rating : 4.4/5 (262 download)

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Book Synopsis Urologic Oncology by : Axel S. Merseburger

Download or read book Urologic Oncology written by Axel S. Merseburger and published by Springer. This book was released on 2019-08-21 with total page 870 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive and timely textbook covers all aspects of the evidence-based management of genitourinary cancers and explains the fundamental principles underlying the available diagnostic and treatment approaches, including chemotherapy, radiotherapy, immunotherapy, and surgery. For each type of cancer – prostate, bladder, renal, testicular, and penile, plus rare urologic malignancies – clinical presentation, diagnosis, and treatment strategies are described in detail and information is provided on etiology, epidemiology, risk factors, and pathology, including TNM classification. Careful attention is also devoted to the complications that may be encountered when treating urologic malignancies and to the management of these complications. The text is complemented by the inclusion of numerous high-definition photographs and illustrations. Urologic Oncology will be a valuable reference and source of guidance for all oncologists, urologists and practitioners in related disciplines who treat patients with urologic cancers.

Castration Resistant Prostate Cancer, An Issue of Urologic Clinics

Author : Adam S. Kibel
Publisher : Elsevier Health Sciences
ISBN 13 : 1455747238
Total Pages : 184 pages
Book Rating : 4.4/5 (557 download)

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Book Synopsis Castration Resistant Prostate Cancer, An Issue of Urologic Clinics by : Adam S. Kibel

Download or read book Castration Resistant Prostate Cancer, An Issue of Urologic Clinics written by Adam S. Kibel and published by Elsevier Health Sciences. This book was released on 2012-11-28 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Castrate Resistant Prostate Cancer is advanced disease that has stopped responding to hormone therapy. This issue of the Urologic Clinics focuses on the various forms of therapy including immunotherapy, first line chemotherapy, and novel targeted agents. Articles on defining the diseae and palliative care are also included.