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| apalutamide fda approval history: Generic Drug Product Development Isadore Kanfer, Leon Shargel, 2016-04-19 Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica |
| apalutamide fda approval history: Hepatotoxicity Hyman J. Zimmerman, 1999 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. |
| apalutamide fda approval history: Cancer Chemotherapy, Immunotherapy, and Biotherapy Bruce A. Chabner, Dan L. Longo, 2024-06-18 Focusing on individual patient needs, Cancer Chemotherapy, Immunotherapy and Biotherapy: Principles and Practice, Seventh Edition, provides thorough, comprehensive information from Drs. Bruce A. Chabner, Dan L. Longo, and an authoritative team of clinicians and scientists working at renowned cancer centers across the globe. It covers fundamental information about mechanism of action, pharmacokinetics, clinical toxicity, and drug interactions, all essential to the safe and effective use of the drug. |
| apalutamide fda approval history: Regulating Medicines in a Globalized World National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Global Health, Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines, 2020-04-25 Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities. |
| apalutamide fda approval history: FDA Approval of New Drugs United States. Food and Drug Administration, 1971 |
| apalutamide fda approval history: Chemotherapy and Immunotherapy in Urologic Oncology Edouard J. Trabulsi, Costas D. Lallas, Anne E. Lizardi-Calvaresi, 2020-09-29 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. |
| apalutamide fda approval history: Concepts and Principles of Pharmacology James E. Barrett, Clive P. Page, Martin C. Michel, 2019-12-24 Celebrating 100 years of HEP, this volume will discuss key pharmacological discoveries and concepts of the past 100 years. These discoveries have dramatically changed the medical treatment paradigms of many diseases and these concepts have and will continue to shape discovery of new medicinies. Newly evolving technologies will similarly be discussed as they will shape the future of the pharmacology and, accordingly, medical therapy. |
| apalutamide fda approval history: Role of Nutraceuticals in Cancer Chemosensitization , 2017-10-18 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 |
| apalutamide fda approval history: Anticancer Agents Qiao-Hong Chen, 2021-03-02 This book is a printed edition of the Special Issue entitled “Anticancer Agents: Design, Synthesis and Evaluation” that was published in Molecules. Two review articles and thirty research papers are included in the Special Issue. Three second-generation androgen receptor antagonists that have been approved by the U.S. FDA for the treatment of prostate cancer have been reviewed. Identification of mimics of protein partners as protein-protein interaction inhibitors via virtual screening has been summarized and discussed. Anticancer agents targeting various protein targets, including IGF-1R, Src, protein kinase, aromatase, HDAC, PARP, Toll-Like receptor, c-Met, PI3Kdelta, topoisomerase II, p53, and indoleamine 2,3-dioxygenase, have been explored. The analogs of three well-known tubulin-interacting natural products, paclitaxel, zampanolide, and colchicine, have been designed, synthesized, and evaluated. Several anticancer agents representing diverse chemical scaffolds were assessed in different kinds of cancer cell models. The capability of some anticancer agents to overcome the resistance to currently available drugs was also studied. In addition to looking into the in vitro ability of the anticancer agents to inhibit cancer cell proliferation, apoptosis, and cell cycle, in vivo antitumor efficacy in animal models and DFT were also investigated in some papers. |
| apalutamide fda approval history: Introduction to Basics of Pharmacology and Toxicology Abialbon Paul, Nishanthi Anandabaskar, Jayanthi Mathaiyan, Gerard Marshall Raj, 2021-03-13 This book explains the pharmacological relationships between the various systems in the human body. It offers a comprehensive overview of the pharmacology concerning the autonomic, central, and peripheral nervous systems. Presenting up-to-date information on chemical mediators and their significance, it highlights the therapeutic aspects of several diseases affecting the cardiovascular, renal, respiratory, gastrointestinal, endocrinal, and hematopoietic systems. The book also includes drug therapy for microbial and neoplastic diseases. It also comprises sections on immunopharmacology, dermatological, and ocular pharmacology providing valuable insights into these emerging and recent topics. Covering the diverse groups of drugs acting on different systems, the book reviews their actions, clinical uses, adverse effects, interactions, and subcellular mechanisms of action. It is divided into 11 parts, subdivided into several chapters that evaluate the basic pharmacological principles that govern the different types of body systems. This book is intended for academicians, researchers, and clinicians in industry and academic institutions in pharmaceutical, pharmacological sciences, pharmacy, medical sciences, physiology, neurosciences, biochemistry, molecular biology and other allied health sciences. |
| apalutamide fda approval history: Clinical Oncology Martin D. Abeloff, 2000 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. |
| apalutamide fda approval history: Pharmacoepidemiology and Pharmacovigilance Sabrina Nour, Gilles Plourde, 2018-10-17 Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. - Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs - Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions - Offers case studies that illustrate real-life clinical situations - Discusses important concepts related to pharmacoepidemiology and pharmacovigilance |
| apalutamide fda approval history: Ending Medical Reversal Vinayak K. Prasad, Adam S. Cifu, 2019-05-14 Why medicine adopts ineffective or harmful medical practices only to abandon them—sometimes too late. Medications such as Vioxx and procedures such as vertebroplasty for back pain are among the medical advances that turned out to be dangerous or useless. What Dr. Vinayak K. Prasad and Dr. Adam S. Cifu call medical reversal happens when doctors start using a medication, procedure, or diagnostic tool without a robust evidence base—and then stop using it when it is found not to help, or even to harm, patients. In Ending Medical Reversal, Drs. Prasad and Cifu narrate fascinating stories from every corner of medicine to explore why medical reversals occur, how they are harmful, and what can be done to avoid them. They explore the difference between medical innovations that improve care and those that only appear to be promising. They also outline a comprehensive plan to reform medical education, research funding and protocols, and the process for approving new drugs that will ensure that more of what gets done in doctors' offices and hospitals is truly effective. |
| apalutamide fda approval history: Oncology in the Precision Medicine Era Ravi Salgia, 2019-12-17 This volume comprehensively reviews oncology in the precision medicine era of personalized care, latest developments in the field, and indications and clinical trials for the treatment of cancer with targeted therapies, immunotherapy, and epigenetic modulators. It thoroughly addresses concerns of various types of cancers including cancers of the head and neck, lung, colon, esophagus, bladder, pancreas, and breast; melanoma; multiple myeloma; hepatocellular carcinoma; renal cell carcinoma; and sarcomas. It is organized and written in a format that is easy to follow for both clinicians and non-clinical scientists interested in personalized medicine. Chapters cover the identification of the clinical problem and summary of recent findings, tumor biology and heterogeneity, genomics, examples of simple and complex cases, biological pathways, future clinical trials, and financial considerations. Oncology in the Precision Medicine Era: Value-Based Medicine will serve as a useful resource for medical oncologists and healthcare providers tailoring medicine to the needs of the individual patient, from prevention and diagnosis to treatment and follow up. |
| apalutamide fda approval history: Practical Medical Oncology Textbook Antonio Russo, Marc Peeters, Lorena Incorvaia, Christian Rolfo, 2021-10-06 This textbook combines essential information on clinical cancer medicine with a guide to the latest advances in molecular oncology and tumor biology. Providing a systematic overview of all types of solid tumors, including epidemiology and cancer prevention, genetic aspects of hereditary cancers, differential diagnosis, typical signs and symptoms, diagnostic strategies and staging, and treatment modalities, it also discusses new and innovative cancer treatments, particularly targeted therapy and immunotherapy. Expert commentaries at the end of each chapter highlight key points, offer insights, suggest further reading and discuss clinical application using case descriptions. This textbook is an invaluable, practice-oriented tool for medical students just beginning their clinical oncology studies, as well as for medical oncology residents and young professionals. |
| apalutamide fda approval history: Highlights of Progress in Research on Cancer , 1957 |
| apalutamide fda approval history: Medicinal Chemistry of Anticancer Drugs Carmen Avendaño, J. Carlos Menéndez, 2015-06-11 Medicinal Chemistry of Anticancer Drugs, Second Edition, provides an updated treatment from the point of view of medicinal chemistry and drug design, focusing on the mechanism of action of antitumor drugs from the molecular level, and on the relationship between chemical structure and chemical and biochemical reactivity of antitumor agents. Antitumor chemotherapy is a very active field of research, and a huge amount of information on the topic is generated every year. Cytotoxic chemotherapy is gradually being supplemented by a new generation of drugs that recognize specific targets on the surface or inside cancer cells, and resistance to antitumor drugs continues to be investigated. While these therapies are in their infancy, they hold promise of more effective therapies with fewer side effects. Although many books are available that deal with clinical aspects of cancer chemotherapy, this book provides a sorely needed update from the point of view of medicinal chemistry and drug design. - Presents information in a clear and concise way using a large number of figures - Historical background provides insights on how the process of drug discovery in the anticancer field has evolved - Extensive references to primary literature |
| apalutamide fda approval history: Biological Mechanisms and the Advancing Approaches to Overcoming Cancer Drug Resistance Andrew Freywald, Franco Vizeacoumar, 2020-12-02 Biological Mechanisms and the Advancing Approaches to Overcoming Cancer Drug Resistance, Volume 12, discusses new approaches that are being undertaken to counteract tumor plasticity, understand and tackle the interactions with the microenvironment, and disrupt the rewiring of malignant cells or bypass biological mechanism of resistance by using targeted radionuclide therapies. This book provides a unique opportunity to the reader to understand the fundamental causes of drug resistance and how different approaches are applied. It is a one-stop-shop to understand why it is so difficult to treat cancer, and why only a very few patients respond to therapy and a significant portion develop resistance. Despite a rapid development of more effective anti-cancer drugs and combination therapies, cancer remains the leading cause of lethality in the developed world. The main reason for this is the ability of heterogeneous subpopulations of tumor cells interacting with constantly evolving tumor microenvironment to resist elimination and eventually, trigger cancer relapse. In this book, experts review current concepts explaining molecular and biological mechanisms of cancer drug resistance and discussing advancing approaches for overcoming these therapeutic challenges. Provides the most updated knowledge on the mechanisms of cancer drug resistance and the emerging therapeutic approaches reviewed by experts in the field Brings detailed analyses of most important recently reported developments related to drug resistance and their relevance to overcoming it in cancer patients Discusses in-depth molecular mechanisms and novel concepts of cancer resistance to conventional and advanced therapies |
| apalutamide fda approval history: Medical Use of Illicit Drugs Kathleen Cronin, 2019-12-15 With the legalization of medical marijuana becoming increasingly common in many states, the medicinal potential of formerly illicit drugs has caught the public's attention. However, marijuana is not the only drug being researched and used medicinally: MDMA, psilocybin, and ketamine have been found to have therapeutic qualities, which leads some to question whether the medical use of these substances may also be legal in the future. This volume helps readers explore issues like regulation, the ethics of using illicit drugs in medical and scientific research, and its place in the greater history of drug regulation in the United States. |
| apalutamide fda approval history: Applied Methods of Cost-effectiveness Analysis in Healthcare Alastair Gray, 2011 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. |
| apalutamide fda approval history: Advancing Healthcare Through Personalized Medicine Priya Hays, 2021-09-27 This book provides a unique perspective on the biomedical and societal implications of personalized medicine and how it helps to mitigate the healthcare crisis and rein in ever-growing expenditure. It introduces the reader to the underlying concepts at the heart of personalized medicine. An innovative second edition, this book functions as an update to the successful first edition to include new, state-of-the-art information and advancements in the fast-paced field of personalized medicine. Chapters examine pharmacogenomics, targeted therapies, individualized diagnosis and treatment, and cancer immunotherapies. The book also features an essential discussion on how the advent of genomic technologies gives clinicians the capability to predict and diagnose disease more efficiently and offers a detailed up-to-date compilation of clinical trials in cancer leading to breakthrough therapies. The book also addresses the impact of Big Data on personalized medicine and the newfound applications of digital health and artificial intelligence. A work that advocates for a patient-centered approach, Advancing Healthcare Through Personalized Medicine, Second Edition is an invaluable text for clinicians, healthcare providers, and patients. |
| apalutamide fda approval history: Male Stress Urinary Incontinence Giulio Del Popolo, Donatella Pistolesi, Vincenzo Li Marzi, 2015-06-18 This book aims to offer a comprehensive and up-to-date overview of male stress urinary incontinence that will serve as a useful tool and reference for urologists, andrologists, physiotherapists, general practitioners, and nurses. Detailed information is provided on diagnostic workup, including clinical assessment and the role of urodynamic evaluations and other instrumental examinations, and on the full range of potential treatments, from conservative and pharmacological interventions to surgical options. In addition to careful descriptions of the surgical procedures themselves, clear advice is given on the management of iatrogenic complications of incontinence surgery. Helpful treatment algorithms and recommendations offer further practical support. Relevant background knowledge is provided in expert reviews of topics such as the functional anatomy of the male pelvis and the pathophysiology, epidemiology, and classification of male urinary incontinence. |
| apalutamide fda approval history: Targeted Therapies in Oncology, Second Edition Giuseppe Giaccone, Jean-Charles Soria, 2013-10-21 Since the last edition of this book, major advances have been made in our understanding of key pathways that control tumor progression. This has led to the development of new anticancer agents that have the ability to block the activity of proteins involved in neoplastic cell development and proliferation. Targeted Therapies in Oncology, Second Edition provides a concise timely panorama of existing targeted therapies and progress into future anticancer treatments. These therapies notably include: Targeted agents of immune checkpoints Signal-transduction inhibitors Antiangiogenic agents Vascular-disrupting agents Apoptosis modulators Stem cell inhibitors Tumor profiling for drug development The book emphasizes the biology behind this new class of drugs as well as the clinical achievements obtained. The contributors to this volume stand at the cutting edge of cancer research and treatment around the world. |
| apalutamide fda approval history: Image Guided Interventions of the Spine Majid Khan, Sergiy V. Kushchayev, Scott H. Faro, 2021-10-18 This book is a comprehensive review of image guided interventions of the spine. Beginning with a chapter dedicated to the history of image guided spinal interventions, authors set the stage for the role these procedures have and will play in the field. Chapters cover the key procedures, techniques, and considerations to maximize effectiveness and patient care. Some major topics covered include: imaging osseo-ligamentous spine anatomy, percutaneous vertebroplasty, image guided tumor ablation, and vascular spine intervention. Additional features include high-quality illustrations with concise descriptions and clinical cases discussions. This is an ideal guide for interventional neuroradiologists, radiologists, pain management physicians, neurosurgeons, orthopedic spine surgeons, and related residents, fellows, and students wanting in depth information on image guided interventions of the spine. |
| apalutamide fda approval history: Stereotactic Body Radiation Therapy Simon S. Lo, Bin S. Teh, Jiade J. Lu, Tracey E. Schefter, 2012-08-28 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. |
| apalutamide fda approval history: Focal Therapy in Prostate Cancer Hashim Uddin Ahmed, Manit Arya, Peter R. Carroll, Mark Emberton, 2011-12-27 This book comprehensively reviews the potential of focal therapy and discusses why the changing face of prostate cancer warrants a change in the way we treat men with the disease. It deals with the mechanisms by which disease can be localized within the gland and then the different technologies used for focal ablation. Bringing together eminent contributors in one accessible reference, this book introduces focal therapy to all urologists, oncologists, and radiologists who are involved in the treatment of men with prostate cancer. |
| apalutamide fda approval history: Androgen Action Fahri Saatcioglu, 2011-08-09 Androgens play a critical role in the development and maintenance of the male reproductive system and affect important physiological processes and pathological conditions, including the homeostasis of the normal prostate and prostate cancer. Androgen Action: Methods and Protocols is designed to provide a tool box to study various phases of androgen action, from its entry to the cell to the phenotypic response that the cell mounts, with up-to-date techniques for biochemists, molecular biologists, cell biologists, geneticists, and pathologists. The volume opens with a brief review of the research history on androgen action and prostate carcinogenesis, followed by chapters that cover state-of-the-art methods to determine androgen levels in biological tissues and fluids, experimental procedures to study the various aspects of androgen receptor activity, and methodology to study salient examples of interactions between androgen signalling and other major signalling pathways in cells. Written in the successful Methods in Molecular BiologyTM series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and easily accessible, Androgen Action: Methods and Protocols provides a comprehensive overview of, and practical guidance on, the diverse methodologies that are propelling androgen action research forward, both for normal physiology as well as in disease states. |
| apalutamide fda approval history: Prostate Cancer Scott M. Dehm, Donald J. Tindall, 2020-01-03 The purpose of this book is to provide a contemporary overview of the causes and consequences of prostate cancer from a cellular and genetic perspective. Written by experts in the fields of epidemiology, toxicology, cell biology, genetics, genomics, cell-cell interactions, cell signaling, hormone signaling, and transcriptional regulation, the text covers aspects of prostate cancer from disease initiation to metastasis. Chapters explore in depth the cells of origin for prostate cancer, its genomic subtypes, neural transcription factors in disease progression, epigenetic regulation of chromatin, and many other topics. This book distinguishes itself from other texts on prostate cancer by its focus on cellular and genetic mechanisms, as opposed to clinical diagnosis and management. As a result, this book will be of broad interest to basic and translational scientists with familiarity of these topics, as well as to trainees at earlier stages of their research careers. |
| apalutamide fda approval history: Molecular Biology of Prostate Cancer Manfred Wirth, J. E. Altwein, B. Schmitz-Dräger, S. Kuptz, 2013-05-22 |
| apalutamide fda approval history: Saunders Nursing Drug Handbook 2020 Robert Kizior, Keith Hodgson, 2019-02-27 The go-to guide for students and nurses alike to promote better patient care! Saunders Nursing Drug Handbook 2020 provides you with essential information on more than 1,000 generic and 4,000 trade name drugs. This handy user-friendly guide features updated Black Box Alerts and comprehensive coverage of IV drug administration, nursing considerations, and fixed combinations. It uniquely guides you through clinical priorities in the practice setting and is organized alphabetically by generic drug name for quick reference. Detailed information for each drug distinguishes side effects and adverse reactions and lists the effect or reaction by frequency of occurrence to allow the nurse to easily identify which are most likely to occur. Plus, new drug monographs cover approximately 32 newly approved drugs by the FDA; and thoroughly updated monographs include new interactions, precautions, and alerts. - Over 1,000 generic name drugs (encompassing over 4,000 trade name drugs) are organized alphabetically with A to Z tabs to make accessing important information quick and easy. - Detailed information for each drug distinguishes side effects and adverse reactions to help you identify which are most likely to occur. - Special text treatment for high-alert drugs that pose the greatest risk for patient harm, as well as an appendix for drug names that sound alike and look alike, help promote safe drug administration. - UNIQUE! Frequently-used herb monographs and herb interactions keep you informed of the effects of commonly encountered herbs.Classifications s - ection features an overview of actions and uses for drug families.T - op 100 Drugs list helps you easily identify the most frequently administered drugs.N - ursing implications are organized in a functional nursing process framework and include headings for Baseline Assessment, Intervention/Evaluation, and Patient/Family Teaching. - Information on lifespan and disorder-related dosage variations equips you with special considerations for pediatric, geriatric, hepatic, and immune-or renal-compromised patients. - Extensively expanded IV content features a heading for IV compatibilities and expanded rates of infusion, reconstitutions, drip rates, test doses, flushing, and incompatibilities. - Fixed combinations are included in dosages of each combined drug directly within the individual monographs to help you understand different drug dose options for specific diseases. - Cross-references to the 400 top U.S. brand-name drugs are located directly in the main section of the book for easier accessibility. - Customizable and printable monographs for 100 of the most commonly used drugs and quarterly drug updates are located on the free Evolve companion site. - Therapeutic and toxic blood level information shows students the patient implications for drug administration. - Comprehensive IV Compatibility Chart foldout arms you with compatibility information for 65 intravenous drugs. - Newly approved drugs are listed in the front of the book for quick and easy access to this timely information. - Highlights the features of a sample drug monograph with callouts to help you understand how to use the book more efficiently. |
| apalutamide fda approval history: Inclusion Steven Epstein, 2010-10 With Inclusion, Steven Epstein argues that strategies to achieve diversity in medical research mask deeper problems, ones that might require a different approach and different solutions. Formal concern with this issue, Epstein shows, is a fairly recent phenomenon. Until the mid-1980s, scientists often studied groups of white, middle-aged men - and assumed that conclusions drawn from studying them would apply to the rest of the population. But struggles involving advocacy groups, experts, and Congress led to reforms that forced researchers to diversify the population from which they drew for clinical research. While the prominence of these inclusive practices has offered hope to traditionally underserved groups, Epstein argues that it has drawn attention away from the tremendous inequalities in health that are rooted not in biology but in society. This edition is in two volumes. The second volume ISBN is 9781458732194. |
| apalutamide fda approval history: Lipid Nanocarriers for Drug Targeting Alexandru Mihai Grumezescu, 2018-04-16 Lipid Nanocarriers for Drug Targeting presents recent advances in the area of lipid nanocarriers. The book focuses on cationic lipid nanocarriers, solid lipid nanocarriers, liposomes, thermosensitive vesicles, and cubosomes, with applications in phototherapy, cosmetic and others. As the first book related to lipid nanocarriers and their direct implication in pharmaceutical nanotechnology, this important reference resource is ideal for biomaterials scientists and those working in the medical and pharmaceutical industries that want to learn more on how lipids can be used to create more effective drug delivery systems. - Highlights the most commonly used types of lipid nanocarriers and explains how they are applied in pharmacy - Shows how lipid nanocarriers are used in different types of treatment, including oral medicine, skin repair and cancer treatment - Assesses the pros and cons of using different lipid nanocarriers for different therapies |
| apalutamide fda approval history: Precision Medicine for Investigators, Practitioners and Providers Joel Faintuch, Salomao Faintuch, 2019-11-16 Precision Medicine for Investigators, Practitioners and Providers addresses the needs of investigators by covering the topic as an umbrella concept, from new drug trials to wearable diagnostic devices, and from pediatrics to psychiatry in a manner that is up-to-date and authoritative. Sections include broad coverage of concerning disease groups and ancillary information about techniques, resources and consequences. Moreover, each chapter follows a structured blueprint, so that multiple, essential items are not overlooked. Instead of simply concentrating on a limited number of extensive and pedantic coverages, scholarly diagrams are also included. - Provides a three-pronged approach to precision medicine that is focused on investigators, practitioners and healthcare providers - Covers disease groups and ancillary information about techniques, resources and consequences - Follows a structured blueprint, ensuring essential chapters items are not overlooked |
| apalutamide fda approval history: World Cancer Report 2014 Bernard W. Stewart, Christopher P. Wild, 2014 World Cancer Report 2014 provides a professional, multidisciplinary assessment of all aspects of the geographical distribution, biology, etiology, prevention, and control of cancer, predicated on research. World Cancer Report is designed to provide non-specialist health professionals and policy-makers with a balanced understanding of cancer control and to provide established cancer professionals with insights about recent developments. |
| apalutamide fda approval history: Campbell Walsh Wein Urology, E-Book Alan W. Partin, Roger R. Dmochowski, Louis R. Kavoussi, Craig A. Peters, Alan J. Wein, 2020-01-21 From the basic science underpinnings to the most recent developments in medical and surgical care, Campbell-Walsh-Wein Urology offers a depth and breadth of coverage you won't find in any other urology reference. Now in three manageable volumes, the revised 12th Edition is a must-have text for students, residents, and seasoned practitioners, with authoritative, up-to-date content in an intuitively organized, easy-to-read format featuring key points, quick-reference tables, and handy algorithms throughout. - Features shorter, more practical chapters that help you find key information quickly. - Includes new chapters on Urinary Tract Imaging: Basic Principles of Nuclear Medicine · Ethics and Informed Consent · Incisions and Access · Complications of Urologic Surgery · Urologic Considerations in Pregnancy · Intraoperative Consultation · Special Urologic Considerations in Transgender Individuals · and more. - Covers hot topics such as minimally invasive and robotic surgery; advancements in urologic oncology, including innovative therapeutics for personalized medicine; new approaches to male infertility; technological advances for the treatment of stones; and advances in imaging modalities. - Incorporates current AUA/EAU guidelines in each chapter as appropriate - Updates all chapters with new content, new advances, and current references and best practices. Extensively updated chapters include Urological Immunotherapy, Minimally Invasive Urinary Diversion, and Updated Focal Therapy for Prostate Cancer. - Features more than 175 video clips, including all-new videos on perineal ultrasound, abdominoplasty in prune belly syndrome, partial penectomy, low dose rate brachytherapy, and many more. - Written and edited by key opinion leaders, reflecting essential changes and controversies in the field. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices. |
| apalutamide fda approval history: Nuclear Receptors as Drug Targets Eckhard Ottow, Hilmar Weinmann, 2008-10-13 Edited by two experts working at the pioneering pharmaceutical company and major global player in hormone-derived drugs, this handbook and reference systematically treats the drug development aspects of all human nuclear receptors, including recently characterized receptors such as PPAR, FXR and LXR. Authors from leading pharmaceutical companies around the world present examples and real-life data from their own work. |
| apalutamide fda approval history: Cardio-Oncology Practice Manual: A Companion to Braunwald's Heart Disease E-Book Joerg Herrmann, 2022-01-11 Today's patients have unique cardiologic needs before, during, and after cancer treatment. Chemotherapies, radiation therapy, and targeted therapies can produce acute side effects or lasting adverse consequences on the heart and circulatory system, making the field of cardio-oncology increasingly important in effective patient care. Cardio-Oncology Practice Manual is a comprehensive, portable guide that provides practical approaches to assessment and management of cardiovascular diseases due to the effects of cardiotoxic agents and treatments. Part of the Braunwald family of renowned cardiology references, it clearly presents clinically relevant aspects of this growing field in one quick, practical reference for a wide range of cardio-oncology providers. - Covers all major cancer therapies, cardiovascular toxicities, and malignancies in a portable, authoritative guide—ideal for cardiologists, cardio-oncologists, general practitioners, internists, medical oncologists, and hematologists. - Offers templated and streamlined content for quick retrieval, with key point summaries for each major section. - Presents cardiac disease entities and specific malignant diseases in a succinct overview format addressing important clinical care aspects. - Features Central Illustrations for each topic that visually summarize the chapter and its specific content including algorithms for management of cardiovascular toxicities and one-view overviews of malignancies. - Includes a comprehensive drug guide that provides quick reference to drugs prescribed for cancers with therapeutic indications, manifestations and mechanisms of cardiotoxicity, their risk factors, and risk reduction strategies. - Brings you up to date with new immune therapies, including immune checkpoint inhibitors and CAR T-cell therapies |
| apalutamide fda approval history: Fluoxetine Graziano Pinna, 2015-04-01 Fluoxetine, best known by the trade name Prozac®, unlike other psychotropic drugs whose effects were serendipitously stumbled upon, was the first developed for a precise mechanism of action, that is, the ability to selectively inhibit serotonin reuptake, based upon the theory that increasing the availability of serotonin would treat major depression. Once approved by the FDA in 1987, fluoxetine quickly became the most prescribed psychotropic drug worldwide and its success in improving mood disorders has triggered the development of a large number of congener molecules, commonly known as SSRIs after their purported mechanism of action. However, a quarter of a century after its development, the idea that fluoxetine asserts its positive behavioral effect through inhibition of serotonergic reuptake is not firmly established. This book reviews several preclinical and clinical reports suggesting that the pharmacological effects of fluoxetine may be mediated by means other than the regulation of serotonin, including the regulation of gene expression, modifying epigenetic mechanisms as well as modifying microRNAs. One of the most prominent mechanisms for the therapeutic relevance of fluoxetine relates to influencing neuroplasticity by enhancing neurotropic factors, including BDNF signaling and altering adult neurogenesis. The ability of fluoxetine to rapidly increase neurosteroid levels accounts for the fast anxiolytic effects of this drug. Fluoxetine action at sigma-1 receptor or modulating glutamatergic neurotransmission as well as the combination of fluoxetine with other psychotropic drugs is discussed in relation to its therapeutic effects. While fluoxetine was primarily prescribed as an antidepressant, this drug currently represents a treatment of choice for a broad spectrum of psychiatric disorders, including post-traumatic stress disorder and a range of anxiety disorders. This drug even possesses analgesic actions and is a valuable therapy for stroke. This book also highlights emerging evidence on the gender-specific effects of fluoxetine, its potential adverse features, including its addiction liability in combination with psychostimulants, and the impact of perinatal fluoxetine exposure. |
| apalutamide fda approval history: Oncology Tumors & Treatment Stanley B. Burns, 2004 A photographic history of oncology, from the collection of renowned physician and historian Stanley B. Burns. |
| apalutamide fda approval history: Pharmacology and Therapeutics Scott A. Waldman, Andre Terzic, 2009 Everything you need to know about all of today's drugs in a coherent, easy-to-use format - from the underlying science through innovation, translation, regulation, and clinical implementation. This multimedia resource fills a critical need for a more clinically focused, user-friendly pharmacology reference. Evidence-based therapeutic guidelines facilitate decision making; and coverage of pharmacogenetics and pharmacogenomics, regenerative pharmacology, stem cell therapies, and the emerging field of individualized medicine keeps you at the forefront of the latest developments. |
CENTER FOR DRUG EVALUATION AND RESEARCH - Food and …
Approval Package for: APPLICATION NUMBER: 210951Orig1s000 Trade Name: Erleada™ oral tablets, 60 mg Generic or Proper Name: apalutamide Sponsor: Janssen Biotech, Inc. Approval …
NCT02489318 - ClinicalTrials.gov
The primary objective is to determine if the addition of apalutamide (JNJ-56021927) to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall …
Erleada (apalutamide) – New drug approval - OptumRx
On February 14, 2018, the FDA announced the approval of Janssen Biotech’s Erleada (apalutamide), for the treatment of patients with non-metastatic, castration-resistant prostate …
Apalutamide: First Global Approval - Springer
A tablet formulation of apalutamide has been approved in the USA, and is the first FDA-approved treatment for nmCRPC [2]. The FDA approval was based on results from the phase III …
Approved Product Monograph 1
ERLEADATM (apalutamide tablets) is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). ERLEADATM has not been studied in …
Apalutamide in the treatment of castrate-resistant prostate …
Drug Administration (US FDA) approval of apalutamide in the nmCRPC setting in February 2018. This review summarizes the clinical development of apalutamide, culminating with the pivotal …
New Treatment Apalutamide Improves Metastasis-Free …
received approval from the Food and Drug Administration, the first time the FDA has approved a drug for nmCRPC. A PIONEERING DRUG FOR NMCRPC In the phase 3 trial, Dr. Smith’s …
Press Release Zydus receives final approval from USFDA for …
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to …
Drug Policy: Erleada (apalutamide) - nhpri.org
To define and describe the accepted indications for Erleada (apalutamide) usage in the treatment of cancer, including FDA approved indications, and off-label indications. Evolent is responsible …
Draft Guidance on Apalutamide August 2024 - Food and Drug …
Document History: Recommended May 2019; Revised August 2024 Unique Agency Identifier: PSG_210951 a For the most recent version of a guidance, check the FDA guidance website at...
Drug Policy: Erleada (apalutamide) - nhpri.org
To define and describe the accepted indications for Erleada (apalutamide) usage in the treatment of cancer, including FDA approved indications, and off-label indications. New Century Health …
This label may not be the latest approved by FDA. For current …
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA 1088 or www.fda.gov/medwatch. See 17 for …
This label may not be the latest approved by FDA. For current …
For current labeling information, please visit https://www.fda.gov/drugsatfda of unstable angina, myocardial infarction, or congestive heart failure within six months of randomization...
This label may not be the latest approved by FDA. For current …
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for …
2. Quality and Quantitative Composition - ndi.fda.moph.go.th
Apalutamide, the active ingredient of ERLEADA, is an androgen receptor inhibitor. The chemical name is (4-[7-(6-Cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl] …
Scientific conclusions and grounds for the variation to the …
Taking into account the PRAC Assessment Report on the PSUR(s) for apalutamide, the scientific conclusions of CHMP are as follows: In view of available data on the risk of DRESS (drug …
This label may not be the latest approved by FDA. For current …
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for …
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
ERLEADA® (apalutamide tablets) is indicated for: the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). the treatment of patients with non-metastatic …
POLICY & PROCEDURE UM ONC 1333 - nhpri.org
To define and describe the accepted indications for Erleada (apalutamide) usage in the treatment of cancer, including FDA approved indications, and off-label indications. New Century Health …
This label may not be the latest approved by FDA. For current …
ERLEADATM (apalutamide) tablets, for oral use . Initial U.S. Approval – 2018 -----INDICATIONS ANDUSAGE ----- ERLEADA is an androgen receptor inhibitor indicated for the treatment of …
CENTER FOR DRUG EVALUATION AND RESEARCH - Food and …
Approval Package for: APPLICATION NUMBER: 210951Orig1s000 Trade Name: Erleada™ oral tablets, 60 mg Generic or Proper Name: apalutamide Sponsor: Janssen Biotech, Inc. Approval …
NCT02489318 - ClinicalTrials.gov
The primary objective is to determine if the addition of apalutamide (JNJ-56021927) to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall …
Erleada (apalutamide) – New drug approval - OptumRx
On February 14, 2018, the FDA announced the approval of Janssen Biotech’s Erleada (apalutamide), for the treatment of patients with non-metastatic, castration-resistant prostate …
Apalutamide: First Global Approval - Springer
A tablet formulation of apalutamide has been approved in the USA, and is the first FDA-approved treatment for nmCRPC [2]. The FDA approval was based on results from the phase III …
Approved Product Monograph 1
ERLEADATM (apalutamide tablets) is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). ERLEADATM has not been studied in …
Apalutamide in the treatment of castrate-resistant prostate …
Drug Administration (US FDA) approval of apalutamide in the nmCRPC setting in February 2018. This review summarizes the clinical development of apalutamide, culminating with the pivotal …
New Treatment Apalutamide Improves Metastasis-Free …
received approval from the Food and Drug Administration, the first time the FDA has approved a drug for nmCRPC. A PIONEERING DRUG FOR NMCRPC In the phase 3 trial, Dr. Smith’s …
Press Release Zydus receives final approval from USFDA for …
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to …
Drug Policy: Erleada (apalutamide) - nhpri.org
To define and describe the accepted indications for Erleada (apalutamide) usage in the treatment of cancer, including FDA approved indications, and off-label indications. Evolent is responsible …
Draft Guidance on Apalutamide August 2024 - Food and …
Document History: Recommended May 2019; Revised August 2024 Unique Agency Identifier: PSG_210951 a For the most recent version of a guidance, check the FDA guidance website at...
Drug Policy: Erleada (apalutamide) - nhpri.org
To define and describe the accepted indications for Erleada (apalutamide) usage in the treatment of cancer, including FDA approved indications, and off-label indications. New Century Health …
This label may not be the latest approved by FDA. For current …
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA 1088 or www.fda.gov/medwatch. See 17 for …
This label may not be the latest approved by FDA. For current …
For current labeling information, please visit https://www.fda.gov/drugsatfda of unstable angina, myocardial infarction, or congestive heart failure within six months of randomization...
This label may not be the latest approved by FDA. For current …
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for …
2. Quality and Quantitative Composition - ndi.fda.moph.go.th
Apalutamide, the active ingredient of ERLEADA, is an androgen receptor inhibitor. The chemical name is (4-[7-(6-Cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl] …
Scientific conclusions and grounds for the variation to the …
Taking into account the PRAC Assessment Report on the PSUR(s) for apalutamide, the scientific conclusions of CHMP are as follows: In view of available data on the risk of DRESS (drug …
This label may not be the latest approved by FDA. For current …
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for …
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
ERLEADA® (apalutamide tablets) is indicated for: the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). the treatment of patients with non-metastatic …
POLICY & PROCEDURE UM ONC 1333 - nhpri.org
To define and describe the accepted indications for Erleada (apalutamide) usage in the treatment of cancer, including FDA approved indications, and off-label indications. New Century Health …
