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| farxiga fda approval history: SELECTIVE SODIUM-GLUCOSE TRANSPORTER-2 (SGLT2) INHIBITORS Diabetes - Book-8 - English Dr. S. Om Goel (MD/DM USA), 2021-02-08 |
| farxiga fda approval history: Synthesis And Applications In Chemistry And Materials (In 4 Volumes) Armando J L Pombeiro, Kamran T Mahmudov, Maria De Fatima Costa Guedes Da Silva, 2024-01-16 Chemistry and Material Sciences naturally depend greatly on Synthesis as the initial stage for the existence of compounds and materials with desired behaviors, within the overall streamline of Design/Synthesis — Properties — Application/Function, and their relations. Such a general approach is of a too wide scope to be properly treated in a single set of publications, but this one on 'Synthesis and Applications in Chemistry and Materials' restricts itself by aiming to show the strength and international character of the current research in synthetic chemistry that is being developed in Portugal or abroad by teams that cooperate with this country. Hence, it gathers representative contributions of main Portuguese research groups and foreign collaborating ones. Nevertheless, the topic should be understood in a wide sense, being open to types of studies with significance on sustainable synthesis and applications in chemistry, materials and/or related sciences. |
| farxiga fda approval history: Frequently Prescribed Medications Michael Mancano, Jason Gallagher, 2010-11-12 Health Sciences & Professions |
| farxiga fda approval history: Medicinal Foods as Potential Therapies for Type-2 Diabetes and Associated Diseases Solomon Habtemariam, 2019-06-08 Medicinal Foods as Potential Therapies for Type-2 Diabetes and Associated Diseases: The Chemical and Pharmacological Basis of their Action focuses on active pharmacological principles that modulate diabetes, associated risk factors, complications and the mechanism of action of widely used anti-diabetic herbal plants—rather than just the nutritional composition of certain foods. The book provides up-to-date information on acclaimed antidiabetic super fruits, spices and other food ingredients. Sections cover diabetes and obesity at the global level, the physiological control of carbohydrate and lipid metabolism, the pathophysiology of type-2 diabetes, the chemistry and pharmacology of a variety of spices, and much more. This book will be invaluable for research scientists and students in the medical and pharmaceutical sciences, medicinal chemistry, herbal medicine, drug discovery/development, nutrition science, and for herbal practitioners and those from the nutraceutical and pharm industries. - Provides background knowledge on type-2 diabetes and its pathophysiology and therapeutic targets down to the molecular level - Explores, in detail, the chemistry or secondary metabolites of the indicated foods that potentially modify diabetes and/or associated diseases - Examines the pharmacological findings on medicinal foods, including available clinical trials |
| farxiga fda approval history: Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk Michael J. Klepper, Barton Cobert, 2010-09-15 Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR) |
| farxiga fda approval history: Nutritional and Therapeutic Interventions for Diabetes and Metabolic Syndrome Debasis Bagchi, Sreejayan Nair, 2012-01-31 Diabetes mellitus affects approximately 20 million people in the US, or nearly 7% of the population. It is expected to increase by 70% within the next 25 years, and numerous epidemiologic studies have demonstrated that type 2 diabetes increases the risk of cardiovascular morbidity and mortality. It is estimated to cost over $92 billion in health care costs and lost productivity. The increased risk is due to the detrimental vascular effects of prolonged exposure to a hyperglycemic, oxidant-rich environment yielding associated cardiovascular risk factors: atherosclerosis, hypertension and clotting abnormalities. Hypertension and dyslipidemia in diabetic patients produces substantial decreases in cardiovascular and microvascular diseases. Nutritional and Therapeutic Interventions for Diabetes and Metabolic Syndrome provides an overview of the current epidemic, outlines the consequences of this crisis and lays out strategies to forestall and prevent diabetes, obesity and other intricate issues of metabolic syndrome. The contributing experts from around the world give this book relevant and up-to-date global approaches to the critical consequences of metabolic syndrome and make it an important reference for those working with the treatment, evaluation or public health planning for the effects of metabolic syndrome and diabetes. Scientific discussion of the epidemiology and pathophysiology of the relationship between diabetes and metabolic syndrome Includes coverage of Pre-diabetes conditions plus both Type I and Type II Diabetes Presents both prevention and treatment options |
| farxiga fda approval history: Therapeutic Strategies for Heart Failure Naoki Sato, 2018-01-24 This book introduces pathophysiology and practical heart failure (HF) management at the acute, in-hospital stages during hospitalization and also in the end-stages of HF. Given its increasing incidence and prevalence, we live in a world that is essentially facing an HF pandemic. A country with an ageing population, Japan is unique in terms of the selection of medical treatment, diagnostic techniques, team managing and other approaches. This book sheds new light on the clinical challenges involved in reducing re-hospitalization and improving patients’ prognosis and ADL/QOL, while also reporting on the status quo in Japan. By highlighting these challenges and the methods used to address them, it will encourage experts around the globe to intensively discuss and accelerate research in this field. Including contributions by authors who have played central roles in managing HF in Japan, the book offers an indispensable guide not only for clinicians, technicians and nurses in this field, but also for general physicians, emergency physicians and all others who are involved in the management of acute and end-stage HF. |
| farxiga fda approval history: Global Perspectives on Childhood Obesity Debasis Bagchi, 2010-10-12 Understanding the complex factors contributing to the growing childhood obesity epidemic is vital not only for the improved health of the world's future generations, but for the healthcare system. The impact of childhood obesity reaches beyond the individual family and into the public arenas of social systems and government policy and programs. Global Perspectives on Childhood Obesity explores these with an approach that considers the current state of childhood obesity around the world as well as future projections, the most highly cited factors contributing to childhood obesity, what it means for the future both for children and society, and suggestions for steps to address and potentially prevent childhood obesity. - This book will cover the multi-faceted factors contributing to the rapidly growing childhood obesity epidemic - The underlying causes and current status of rapidly growing obesity epidemic in children in the global scenario will be discussed - The strategies for childhood obesity prevention and treatment such as physical activity and exercise, personalized nutrition plans and school and community involvement will be presented |
| farxiga fda approval history: The Diabetic Kidney Pedro Cortes, 2007-11-06 A comprehensive and authoritative survey of recent findings, ideas, and hypotheses about the causes and treatment of diabetic nephropathy. The authors cover both the basic pathogenic mechanisms of the disease, as well as many of its clinical aspects of identification, management, and new therapeutic approaches. Highlights include an entire section devoted to novel approaches to studying diabetic nephropathy with the most advanced molecular techniques, and complete descriptions of the most up-to-date views on the diagnosis and treatment of the disease. The Diabetic Kidney offers both researchers and practicing clinicians a clear understanding of the of the progress that has been made regarding the pathogenesis of diabetic nephropathy and of the therapeutic interventions needed to prevent its development or treat it. |
| farxiga fda approval history: The Practical Guide , 2002 |
| farxiga fda approval history: Family Nurse Practitioner Certification Review Stewart, Nancy Dennert, 2017 Family Nurse Practitioner Certification Review is an ideal study guide for new and recertifying nurses preparing to take the Family Nurse Practitioner certification exam administered by the ANCC and AAANPCP. Written by nurse practitioners, it offers up-to-date questions and answer rationales specific to FNP certification that reflect the most current guidelines. In addition, it offers a short theory review, clinical application of knowledge, and clinical skills. Also incorporated are ethical and legal considerations, scope of practice, and cultural sensitivity. -- Back cover |
| farxiga fda approval history: FDA's Drug Review Process and the Package Label Tom Brody, 2017-12-01 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 |
| farxiga fda approval history: Synopsis of Neurology, Psychiatry and Related Systemic Disorders Alan B. Ettinger, Deborah M. Weisbrot, Casey E. Gallimore, 2019-05-31 Symptoms and signs in neurology and psychiatry typically present in the clinical context of other underlying conditions. When evaluating a patient, a physician may choose to review a diverse list of potential underlying diagnoses with the aid of the editor team's existing text: Neurological Differential Diagnosis: A Case-Based Approach. However, if the patient has a known pre-existing condition, the physician will need to consider a reverse approach - considering what complications of that condition may be associated with current symptoms. This book provides quick-reference, comprehensive, concise summaries of neurologic, psychiatric and medical diagnoses with a focus on neurologic and psychiatric implications of systemic disorders. A separate pharmacology section provides a consolidated review of potential neurologic and psychiatric adverse effects of medications. This book is an invaluable resource for a broad medical audience, from the medical student to the experienced consultant. |
| farxiga fda approval history: Incretin Based Therapies Sanjay Kalra, Rakesh Sahay, Ambika G Unnikrishnan, 2013-03-31 Incretins are a group of gastrointestinal hormones that cause an increase in the amount of insulin released from cells in the pancreas after eating. Incretin based drugs are used to control blood sugar levels in the management of diabetes. This book is a concise guide to incretin based therapy. Beginning with an introduction to the history and physiology of incretins, the following sections examine the clinical pharmacology of GLP-1 Analogues and DPP-4 Inhibitors, the pleiotrophic effects of incretins and comparative pharmacology. Each section integrates science with practical therapeutic guidance for clinicians involved in the management of diabetes. The final chapter discusses the future of incretin therapies, including non-diabetic usage and combination therapy. Key Features Concise overview of incretin based therapy for the management of diabetes Guides clinicians step by step through the history and pharmacology of various molecules Integrates science with practical therapeutic guidance Includes chapter on the future of incretin therapy |
| farxiga fda approval history: Validamycin and Its Derivatives Xiaolong Chen, Yuele Lu, Yongxian Fan, Yinchu Shen, 2017-03-31 Validamycin and Its Derivatives: Discovery, Chemical Synthesis and Biological Activity presents, for the first time, a complete review of the underlying chemistry, synthesis, behavior and application of these compounds. Beginning with an introduction to validamycin, the book then outlines the key elements of its discovery and production, including details of its structures, isolation, analysis, and issues relating to its large scale production. Biological activities are then explored in more detail, followed by details of biosynthesis. Further to this, the chemical synthesis of validamycin and its intermediates, including valienamine, validamine, valiolamine, and validoxylamines is reviewed, before preparation of these derivatives and their biological activities are explored. Finally, the book concludes with a discussion of the economic aspects of working with validamycin and its potential in future applications and trends. With its detailed chemical coverage from a team of expert authors, this detailed guide can be applied to the large-scale industrial production of antibiotics and the adaptation of bioactive agents, from agricultural, to novel pharmaceutical applications. - Offers complete coverage of validamycin chemistry from a highly experienced team of authors - Encourages the discovery of further novel drugs based on validamycin derivatives - Presents an interesting model for establishing new pharmaceutical leads from agricultural sources - Includes coverage of the total chemical synthesis of validamycin and its intermediates, including valienamine, validamine, valiolamine and validoxylamines |
| farxiga fda approval history: Geriatric Practice Audrey Chun, 2019-10-29 This book serves as a comprehensive reference for the basic principles of caring for older adults, directly corresponding to the key competencies for medical student and residents. These competencies are covered in 10 sections, each with chapters that target the skills and knowledge necessary for achieving competency. Each of the 45 chapters follow a consistent format for ease of use, beginning with an introduction to the associated competency and concluding with the most salient points for mastery. Chapters also includes brief cases to provide context to the clinical reasoning behind the competency, strengthening the core understanding necessary to physicians of the future. Written by expert educators and clinicians in geriatric medicine, Geriatric Practice is key resource for students in geriatric medicine, family and internal medicine, specialties, hospice and nursing home training, and all clinicians studying to work with aging patients. |
| farxiga fda approval history: Joslin's Diabetes Mellitus Elliott Proctor Joslin, C. Ronald Kahn, 2005 The bible on diabetes mellitus is now in its Fourteenth Edition—thoroughly revised and updated by more than 80 noted experts from the Joslin Diabetes Center and other leading institutions worldwide. This edition includes a new eleven-chapter section on hormone action and the regulation of metabolism. The section on definition and pathogenesis now includes chapters on genetics, diabetes in Asia and Africa, and diabetes in U.S. minority groups. Other new chapters cover retinopathy, cardiovascular disease, wound healing, and treatment of women with diabetes. All of the Fourteenth Edition's figures have been completely updated. |
| farxiga fda approval history: Managing Type 2 Diabetes For Dummies American Diabetes Association, 2018-02-13 Discover how to manage diabetes for a healthier and happier life! Written for anyone diagnosed with type 2 diabetes (and for anyone who loves someone with diabetes), Managing Type 2 Diabetes For Dummies is an essential guide to understanding the effects of diabetes and knowing what steps to take to successfully manage this chronic illness. Diabetes can lead to serious complications but people with diabetes can control the condition and lower the risk of its many complications. This is your easy-to-understand guide that shows you how. Under the direction of The American Diabetes Association, Managing Type 2 Diabetes For Dummies gives hope to the one in 11 people in the United States who are affected by the disease. Written in simple-to-understand terms, Managing Type 2 Diabetes For Dummies is filled with a wealth of expert advice and includes the most current information on recent medical advances for treatment. Improperly managed diabetes and consistently high blood glucose levels can lead to serious diseases affecting the heart and blood vessels, eyes, kidneys, nerves, and teeth. With the authorities at the American Diabetes Association on your side, you will have a practical handbook for preventing complications and managing diabetes with confidence! Prevent and manage the complications of the disease Combat diabetes-related anxiety and depression Lead a healthy life with type 2 diabetes Tap into the better living “rules of the road” with Managing Type 2 Diabetes For Dummies. By modifying your diet, consulting with your doctors, staying active, and understanding what medications are right for you, you will be on the path to a happier and healthier lifestyle. |
| farxiga fda approval history: The Metabolism Miracle Diane Kress, 2010-07 There is a reason that some people can eat all they want and seemingly never gain a pound, while others count every calorie, exercise, and can't lose an ounce. Millions of people - an estimated 45 percent of dieters - have Metabolism B, a condition that causes the body to over-process carbohydrate foods into excess body fat. Registered dietitian Diane Kress's scientifically based, easy-to-follow program has helped thousands of people with Metabolism B lose weight and keep it off. As someone who struggled with Metabolism B for years, Kress knows firsthand the frustration of diets that don't work. The solution? A simple, three-step, carb-controlling program that stabilizes blood glucose levels and reprograms the metabolism to melt away fat. The Metabolism Miracle starts working on Day 1. |
| farxiga fda approval history: Discovery and Development of Antidiabetic Agents from Natural Products Goutam Brahmachari, 2016-10-11 Discovery and Development of Antidiabetic Agents from Natural Products brings together global research on the medicinal chemistry of active agents from natural sources for the prevention and treatment of diabetes and associated disorders. From the identification of promising leads, to the extraction and synthesis of bioactive molecules, this book explores a range of important topics to support chemists in the discovery and development of safer, more economical therapeutics that are desperately needed in response to this emerging global epidemic. Beginning with an overview of bioactive chemical compounds from plants with anti-diabetic properties, the book goes on to outline the identification and extraction of anti-diabetic agents and antioxidants from natural sources. It then explores anti-diabetic plants from specific regions before looking more closely at the background, isolation, and synthesis of key therapeutic compounds and their derivatives, including Mangiferin, Resveratrol, natural saponins, and alpha-glucosidase enzyme inhibitors. The book concludes with a consideration of current and potential future applications. Combining the expertise of specialists from around the world, this volume aims to support and encourage medicinal chemists investigating natural sources as starting points for the development of standardized, safe, and effective antidiabetic therapeutics. - Contains chapters written by active researchers and leading global experts who are deeply engaged in the research field of natural product chemistry for drug discovery - Provides comprehensive coverage of cutting-edge research advances in the design of medicinal natural products with potential as preventives and therapeutics for diabetes and related metabolic issues - Presents a practical review of the identification, isolation, and extraction techniques that help support medicinal chemists in the lab |
| farxiga fda approval history: Osteoporosis Christine Junge, 2013-01-01 Osteoporosis can be intimidating and inhibiting. The prospect that a simple fall could break your hip or wrist can make you watch every step you take. Fear can replace the freedom to do all the things you love. The two major risk factors for osteoporosis are being a woman and having passed through menopause. In the years after menopause, women can lose up to one-fifth of their bone mass. But men aren't immune to the disease. Two million American men have osteoporosis and one in four over age 50 will suffer an osteoporosis-related fracture. In Osteoporosis: A guide to prevention and treatment, Harvard Medical School doctors will show you the positive, proactive, and practical steps you can take to protect your bones now and in the years ahead. You will be alerted to red flags that signal you’re at greater risk for a broken bone. You'll be warned about medications that hasten bone loss. And you’ll find out if you should have your bone density checked — and which tests are the best. The report will show you the importance of getting calcium from food and vitamin D from sunlight. You’ll learn about other bone-protective strategies, too, including specific exercise routines, and discover some surprising foods that help weaken bones. Osteoporosis is not inevitable. The good news is there’s a lot you can do to shield your bones from this disease. And the sooner you act, the better off you — and your bones — will be. |
| farxiga fda approval history: Diabetic Retinopathy and Cardiovascular Disease C. Sabanayagam, T.Y. Wong, 2019-06-03 Diabetic retinopathy (DR), a common microvascular complication, has consistently been shown to be associated with an increased risk of cardiovascular disease (CVD). This book provides complete coverage of DR as a potential marker for CVD in those with diabetes. It succinctly reviews the epidemiological and pathogenic links of DR to various cardiovascular events including stroke, coronary artery disease, chronic kidney disease, heart failure, and mortality. Furthermore, it discusses the usefulness of DR in CVD risk prediction and cardiovascular safety of anti-VEGF therapy in diabetic patients. There are insights from contemporary diabetic trials that demonstrated the enhanced cardiovascular benefit of novel glucose lowering therapy. It also highlights the potential of novel retinal imaging to predict CVD and its risk factors using the state-of-the art artificial intelligence-based deep learning systems. This book will be an invaluable resource for specialists translating research findings into clinical care, including those in cardiology, endocrinology, ophthalmology, and general practitioners. IT will also be of interest to public health practitioners, researchers, graduate students, and biotech companies interested in developing retinal image-based diagnostic and prognostic tools. |
| farxiga fda approval history: FDA Approval of New Drugs United States. Food and Drug Administration, 1971 |
| farxiga fda approval history: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) The Law The Law Library, 2018-09-23 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce. This book contains: - The complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section |
| farxiga fda approval history: Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors in Heart Failure Mukesh Nandave, |
| farxiga fda approval history: Polycystic Ovary Syndrome Andrea Dunaif, R. Jeffrey Chang, Stephen Franks, Richard S. Legro, 2008-01-12 This volume includes the latest diagnostic criteria for PCOS and comprises the most up-to-date information about the genetic features and pathogenesis of PCOS. It critically reviews the methodological approaches and the evidence for various PCOS susceptibility genes. The book also discusses additional familial phenotypes of PCOS and their potential genetic basis. All four editors of this title are extremely prominent in the field of PCOS. |
| farxiga fda approval history: Medical Pharmacology and Therapeutics E-Book Derek G. Waller, Tony Sampson, 2013-08-07 This book covers all the pharmacology you need, from basic science pharmacology and pathophysiology, through to clinical pharmacology to therapeutics, in line with the integrated approach of new medical curricula. The first section covers the basic principles, and the rest is organised by body systems. The book ends with sections on toxicity and prescribing practice. Integrates basic science pharmacology, clinical pharmacology and therapeutics Brief review of pathophysiology of major diseases Case histories and multiple choice questions (and answers) Tabular presentation of all common drugs within each class Section on further reading Kinetics chapter simplified with more practical examples Includes more on genetic issues Drug tables made more concise to make information more accessible Fully updated to reflect current clinical practice |
| farxiga fda approval history: Safety of Biologics Therapy Brian A. Baldo, 2016-08-12 This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences. |
| farxiga fda approval history: The Athlete’s Guide to Diabetes Sheri R. Colberg, 2019-02-08 Diabetes doesn’t have to slow you down. Whether you’re a recreational exerciser or a competitive athlete, The Athlete’s Guide to Diabetes has the training and performance advice you need to remain active while effectively managing your condition. Renowned researcher and diabetes expert Dr. Sheri Colberg offers best practices and tips for managing blood glucose levels for athletes of all ages with type 1 and type 2 diabetes. She provides the most up-to-date information on insulin and other medications and their effects on exercise, nutritional practices and supplements, including low-carbohydrate eating, the latest technologies used to manage glucose, including continuous glucose monitoring (CGM), injury prevention and treatment as well as tactics for diabetes-related joint issues, and mental strategies for maximizing performance and optimizing health. You’ll find 15 profiles of athletes with type 1 diabetes who share their accomplishments and how they manage medications, food intake, and other tools available to manage their activities with diabetes. Guidelines for 165 different sports and activities will reduce your trial and error when it comes to performing and feeling your best during fitness activities, endurance sports, endurance–power sports, power sports, and outdoor activities. The Athlete’s Guide to Diabetes adheres to latest guidelines from such trusted sources as the American Diabetes Association and the American College of Sports Medicine. It is the one resource you can’t be without if you want to stay healthy and active, train smarter, and reach new levels of athletic success without losing control of your blood glucose management. Earn continuing education credits/units! A continuing education exam that uses this book is also available. It may be purchased separately or as part of a package that includes both the book and exam. |
| farxiga fda approval history: Ferri's Clinical Advisor 2023, E-Book Fred F. Ferri, 2022-06-21 For 25 years, Ferri's Clinical Advisor has provided immediate answers on the myriad medical diseases and disorders you're likely to encounter in a unique, easy-to-use format. A bestselling title year after year, this popular 5 books in 1 reference delivers vast amounts of information in a user-friendly manner. It is updated annually to provide current and clinically relevant answers on over 1,000 common medical conditions, including diseases and disorders, differential diagnoses, clinical algorithms, laboratory tests, and clinical practice guidelines?all carefully reviewed by experts in key clinical fields. Extensive algorithms, along with hundreds of high-quality photographs, illustrations, diagrams, and tables, ensure that you stay current with today's medical practice. - Contains significant updates throughout all 5 sections, covering all aspects of diagnosis and treatment. - Features 27 all-new topics including coronary artery dissection, perimandibular abscess, retinal vein occlusion, performance enhancing hormones, aphasia, hemorrhagic ovarian cyst, pelvic fracture, lung transplant, penile cancer and obsessive rumination syndrome, among others. - Includes useful appendices covering care of the transgender patient, palliative care, preoperative evaluation, nutrition, poison management, commonly used herbal products in integrated medicine, and much more. - Offers online access to Patient Teaching Guides in both English and Spanish. |
| farxiga fda approval history: Carbohydrates in Drug Discovery and Development Vinod K. Tiwari, 2020-08-01 Carbohydrates in Drug Discovery and Development: Synthesis and Applications examines recent and notable developments in the synthesis, biology, therapeutic, and biomedical applications of carbohydrates, which is considered to be a highly promising area of research in the field of medicinal chemistry. Their role in several important biological processes, notably energy storage, transport, modulation of protein function, intercellular adhesion, malignant transformation, signal transduction, viral, and bacterial cell surface recognition formulate the carbohydrate systems to be an exceedingly considerable scaffold for the development of new chemical entities of pharmacological importance. In addition to their easy accessibility, high functionality and chiralpool characteristics are the few additional fascinating structural features of carbohydrates, which further enhance their utilities and thus they have been able to attract chemists and biologists toward harnessing these properties for the past several decades.This book covers an advanced aspect of carbohydrate-based molecular scaffolding, starting with a general introduction followed by a detailed discussion about the impact of diverse carbohydrate-containing molecules of great therapeutic values and their impact on drug discovery and development. The topics covered in this book include the significance of heparin mimetics as the possible tools for the modulation of biology and therapy, chemistry and bioactivities of C-glycosylated compounds, inositols, iminosugars, KDO, sialic acids, glycohybrids, macrocycles, plant oligosaccharides, anti-bacterial and anti-cancer vaccines, antibiotics, and more. |
| farxiga fda approval history: Understanding Racial and Ethnic Differences in Health in Late Life National Research Council, Division of Behavioral and Social Sciences and Education, Committee on Population, Panel on Race, Ethnicity, and Health in Later Life, 2004-09-08 As the population of older Americans grows, it is becoming more racially and ethnically diverse. Differences in health by racial and ethnic status could be increasingly consequential for health policy and programs. Such differences are not simply a matter of education or ability to pay for health care. For instance, Asian Americans and Hispanics appear to be in better health, on a number of indicators, than White Americans, despite, on average, lower socioeconomic status. The reasons are complex, including possible roles for such factors as selective migration, risk behaviors, exposure to various stressors, patient attitudes, and geographic variation in health care. This volume, produced by a multidisciplinary panel, considers such possible explanations for racial and ethnic health differentials within an integrated framework. It provides a concise summary of available research and lays out a research agenda to address the many uncertainties in current knowledge. It recommends, for instance, looking at health differentials across the life course and deciphering the links between factors presumably producing differentials and biopsychosocial mechanisms that lead to impaired health. |
| farxiga 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. |
| farxiga fda approval history: Type 2 Diabetes in Children and Adolescents Arlan L. Rosenbloom, Janet H. Silverstein, 2003 As a consequence of the obesity epidemic, the prevalence of type 2 diabetes in children and adolescents is increasing. For medical trend watchers and health care professionals alike, this groundbreaking book covers epidemiology of type 2 diabetes in youth; pathophysiology of type 2 in youth; case-finding criteria; early recognition of risk factors; prevention of obesity in this population; and more. |
| farxiga fda approval history: Preparing for Future Products of Biotechnology National Academies of Sciences, Engineering, and Medicine, Division on Earth and Life Studies, Board on Chemical Sciences and Technology, Board on Agriculture and Natural Resources, Board on Life Sciences, Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, 2017-07-28 Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood. |
| farxiga fda approval history: Diabetes Management, An Issue of Primary Care: Clinics in Office Practice, E-Book Lenard (Lenny) Salzberg, 2022-05-24 In this issue, guest editors bring their considerable expertise to this important topic.Provides in-depth reviews on the latest updates in the field, providing actionable insights for clinical practice. Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create these timely topic-based reviews. |
| farxiga fda approval history: Preventing Medication Errors Institute of Medicine, Board on Health Care Services, Committee on Identifying and Preventing Medication Errors, 2006-12-11 In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors. |
| farxiga fda approval history: A Prioritized Research Agenda for Prevention and Control of Noncommunicable Diseases World Health Organization, 2011 Accompanying CD-ROM contains working papers, reports of meetings to develop the prioritized NCD research agenda (2008-2010), lists of participants, list of other contributors and institutions that participated and research priorities for cardiovascular disease prevention and control. |
| farxiga fda approval history: Take Control of Your Cancer Risk John Whyte, MD, MPH, 2021-10-05 Something everyone has the power to do is reduce your cancer risk, and this book will show you just how easy it is to do it. Each year, over a million people in the United States alone hear the words no one ever wants to hear: You have cancer. But what if there was a way for fewer people to hear these words? One of the biggest myths regarding cancer is that it’s mostly genetic - meaning that you have no control over whether you get it. While genetics do have an impact, the truth is that your lifestyle and environment play the major role. Physician and Chief Medical Offer of WebMD John Whyte, MD, MPH, shares straightforward information and equips you with strategies to help you on a journey to better health. In Take Control of Your Cancer Risk, Dr. Whyte provides helpful tips including: assessing your cancer risk knowing which screenings you need, and when learning the role food, exercise, and sleep play understanding the relationship between stress and cancer Take Control of Your Cancer Risk is filled with practical advice that empowers you to really take control of our health. |
| farxiga fda approval history: Toxicological Profile for Benzidine , 1995 |
Farxiga: Uses, Dosage, Side Effects & Warnings - Drugs.com
Sep 2, 2024 · Farxiga can cause the following serious side effects. Diabetic ketoacidosis (increased ketones in …
What is Farxiga used for and how does it work? - Drugs.com
May 7, 2025 · Farxiga works in a part of the kidneys called the proximal renal tubule. It is a sodium-glucose …
Dapagliflozin: Uses, Dosage, Side Effects, Warnings - Drugs…
Mar 25, 2025 · Dapagliflozin (Farxiga) is an SGLT2 inhibitor that is mainly used alongside diet and exercise to help …
Farxiga Patient Tips: 7 things you should know - Drugs.com
Jun 18, 2024 · Farxiga is not recommended during the second and third trimester of pregnancy and …
Farxiga Side Effects: Common, Severe, Long Term - Drugs.com
May 30, 2025 · Farxiga side effects can vary depending on the individual. Always consult your healthcare …
Farxiga: Uses, Dosage, Side Effects & Warnings - Drugs.com
Sep 2, 2024 · Farxiga can cause the following serious side effects. Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other …
What is Farxiga used for and how does it work? - Drugs.com
May 7, 2025 · Farxiga works in a part of the kidneys called the proximal renal tubule. It is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. SGLT2 allows glucose to be reabsorbed …
Dapagliflozin: Uses, Dosage, Side Effects, Warnings - Drugs.com
Mar 25, 2025 · Dapagliflozin (Farxiga) is an SGLT2 inhibitor that is mainly used alongside diet and exercise to help treat type 2 diabetes, but it is also used in the treatment of heart failure.
Farxiga Patient Tips: 7 things you should know - Drugs.com
Jun 18, 2024 · Farxiga is not recommended during the second and third trimester of pregnancy and there is a lack of data assessing the risk for the first trimester of pregnancy. However, the …
Farxiga Side Effects: Common, Severe, Long Term - Drugs.com
May 30, 2025 · Farxiga side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal …
Farxiga: Package Insert / Prescribing Information - Drugs.com
FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization …
Farxiga Dosage Guide - Drugs.com
Oct 24, 2024 · The recommended dosage of FARXIGA in patients with an eGFR greater than or equal to 25 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal …
Farxiga Interactions Checker - Drugs.com
Farxiga Interactions. There are 372 drugs known to interact with Farxiga (dapagliflozin), along with 4 disease interactions, and 1 alcohol/food interaction. Of the total drug interactions, 2 are …
How long does it take for Farxiga to work? - Drugs.com
Apr 25, 2025 · However, it takes multiple doses of once-daily Farxiga to decrease a patient's blood glucose or sugar levels, meaning that it may take a week for Farxiga to take full effect. In …
Farxiga Reviews & Ratings - Drugs.com
For Type 2 Diabetes "Started taking 10mg Farxiga about 1 year ago, within 1 week I had developed Balanoposthitis (inflammation of the head of the penis), which I seem to now have …
