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| cimzia instructions for use: Formulation and Device Lifecycle Management of Biotherapeutics Beate Bittner, Johannes Schmidt, 2022-01-14 Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients. Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-related healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution. - Summarizes formulation and device lifecycle management activities that enable customer-centric and sustainable drug delivery for biotherapeutics - Describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies - Details established clinical development pathways supporting the approval of automated subcutaneous injection devices and proposes novel concepts - Discusses how to realize home- and self-administration of biotherapeutics in cancer care - Highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas and introduces a decision architecture on when and how drug developers should embark into related development activities |
| cimzia instructions for use: Complete Guide to Prescription and Nonprescription Drugs 2015 Henry Winter Griffith, 2014-11-04 The outstanding reference source' is back: updated, revised, and expanded. This newly revised, expanded 2015 edition of the bestselling reference book by one of America's most trusted family physicians gives you the information you need and can depend on.' |
| cimzia instructions for use: 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 |
| cimzia instructions for use: Management of Psoriasis Nikhil Yawalkar, 2009 Treatments for psoriasis, besides affecting the skin, may be associated with various comorbidities (for instance, depression, psoriatic arthritis, Crohn's disease and, in severe psoriasis, metabolic syndrome and cardiovascular diseases), which often presents a therapeutic challenge to physicians.Written by renowned experts, this volume gives a comprehensive overview of psoriasis and its various comorbidities. It describes the treatment modalities for mild and moderate-to-severe psoriasis, including topical, phototherapeutic and conventional systemic treatments (e.g. acitretine, methotrexate and cyclosporine), as well as biological therapies (e.g. alefacept, efalizumab, etanercept, adalimumab and infliximab). The chapters on biological therapies focus on key safety issues. Further chapters focus on such topics as the management of childhood psoriasis and psoriasis in distinctive locations, such as the scalp, face, flexures, palm/soles and nails. Finally, future therapeutic modalities, with the focus on small molecules and potential biological therapies, are discussed.This publication will make significant reading to dermatologists and all physicians dealing with psoriasis, such as general practitioners, psychiatrists, rheumatologists, cardiologists and diabetologists. |
| cimzia instructions for use: 2016 Oncology Nursing Drug Handbook Gail M. Wilkes, Margaret Barton-Burke, 2015-02-11 Written especially for nurses caring for patients with cancer, the 2016 Oncology Nursing Drug Handbook uniquely expresses drug therapy in terms of the nursing process: nursing diagnoses, etiologies of toxicities, and key points for nursing assessment, intervention, and evaluation. |
| cimzia instructions for use: Complete Guide to Prescription & Nonprescription Drugs 2016-2017 H. Winter Griffith, 2015-11-17 The classic guide to all major prescription and nonprescription drugs, featuring revised, up-to-date FDA information and an A–Z list of illnesses for easy reference. Includes coverage of dosage and length of time before a drug takes effect; side effects; special precautions; interactions with other food and drugs; standards for use by different age groups; and more. From the Trade Paperback edition. |
| cimzia instructions for use: Complete Guide to Prescription & Nonprescription Drugs 2018-2019 H. Winter Griffith, 2017-11-07 The classic guide to all major prescription and nonprescription drugs, featuring revised, up-to-date FDA information and an A–Z list of illnesses for easy reference. Includes coverage of dosage and length of time before a drug takes effect; side effects; special precautions; interactions with other food and drugs; standards for use by different age groups; and more. |
| cimzia instructions for use: Handbook of Therapeutic Antibodies Stefan Dübel, Janice M. Reichert, 2014-12-03 Dieses Nachschlagewerk zu therapeutischen Antikörpern sucht auch in der komplett überarbeiteten 2. Auflage seinesgleichen und bietet 30 % neue Inhalte zu Entwicklung, Herstellung und therapeutischen Anwendungen dieser Biomoleküle. |
| cimzia instructions for use: Clinical Drug Data, 11th Edition Kelly Smith, Daniel M. Riche, Nickole Henyan, 2010-04-15 The best single resource available for evaluating and comparing more than 1200 commonly-used medications 4 STAR DOODY'S REVIEW! Although the primary audience for this book is practicing pharmacists, clinical pharmacists, pharmacy residents, and pharmacy students, the wide range of audiences who may benefit from this book include physicians and medical residents who may find this a useful resource, especially with the downloadable option....This is a useful and easy to use reference. Information is systematically organized in an easy to retrieve way.--Doody's Review Service ...will be useful to all health care professionals in a clinical setting. - Review of an earlier edition from the Australian Journal of Hospital Pharmacy Now includes PDA download of the entire text! Uniquely designed to allow comparisons within drug categories, Handbook of Clinical Drug Data is the most comprehensive, well-referenced book available on the selection, use, and clinical aspects of virtually any drug. Compiled by expert clinicians, this quick-access guide delivers the data you need to prevent adverse drug reactions in your patients and help you select drugs for both general and special patient populations Features Full-text PDA download More than 3800 literature citations Comparison charts of drugs by class facilitates clinical decision making Tables to help you rapidly identify the cause of adverse drug effects in patients Guidance on the optimal choice of drugs in special populations, including pregnant and breastfeeding women, and geriatric patients Genetic and ethic considerations Extensively cross-referenced index includes Canadian and British drug names Valuable appendices that include Conversion Factors, Anthropometrics, Laboratory Indices, Pharmacokinetic Equations, and more |
| cimzia instructions for use: CDC Yellow Book 2018: Health Information for International Travel Centers for Disease Control and Prevention CDC, 2017-04-17 THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad. |
| cimzia instructions for use: Medical-Surgical Nursing Sharon Mantik Lewis, Margaret McLean Heitkemper, Jean Foret Giddens, Shannon Ruff Dirksen, 2003-12-01 Package includes Medical-Surgical Nursing: Assessment and Management of Clinical Problems Two Volume text and Virtual Clinical Excursions 2.0 |
| cimzia instructions for use: Treatment of Non-infectious Uveitis Phoebe Lin, Eric Suhler, 2019-09-12 This unique, comprehensive book provides a much-needed reference on the treatment and management of non-infectious uveitis. Carefully designed, Treatment of Non-infectious Uveitis is the first book of its kind to provide an in-depth, clinically-relevant, expert-driven resource for ophthalmologists focusing on modalities of uveitis treatment, their mechanism of action, dosing, and side effects. Each chapter provides an introduction, mechanism of action, indication, dosage, side effects, and efficacy summaries from clinical trials and other published literature. Topics range from topical treatment, to locally administered therapy including drug-releasing implants, to systemic immunosuppressive treatments both tried and new, as well as surgical management, with each chapter highlighting important practice pearls as well as easy-reference dosing tables, side effects, and lab monitoring pertinent to the agents discussed. The book concludes with a discussion of novel approaches to the treatment of non-infectious uveitis, and special considerations when treating uveitis in the pediatric patient. The majority of patients with non-infectious uveitis are treated by comprehensive ophthalmologists, many of whom are less familiar with established treatment guidelines outlining the role of corticosteroids and immunomodulatory therapy. While the non-specialist, resident, or fellow is sure to benefit from this one-stop guide to uveitis treatment, retina and uveitis specialists alike will also appreciate the practice tips and thorough coverage of this expertly-written reference. Treatment of Non-infectious Uveitis is the ideal reference for all ophthalmologists who seek to improve their understanding of the causes of uveitis and learn how to best treat this condition. |
| cimzia instructions for use: Medical-Surgical Nursing - Single-Volume Text and Elsevier Adaptive Learning Package Sharon L. Lewis, Shannon Ruff Dirksen, Margaret M. Heitkemper, Linda Bucher, 2014-06-17 Corresponding chapter-by-chapter to Medical-Surgical Nursing, 9e, Elsevier Adaptive Learning combines the power of brain science with sophisticated, patented Cerego algorithms to help you learn faster and remember longer. It's fun; it's engaging; and it's constantly tracking your performance and adapting to deliver content precisely when it's needed to ensure core information is transformed into lasting knowledge. Please refer to the individual product pages for the duration of access to these products. An individual study schedule reduces cognitive workload and helps you become a more effective learner by automatically guiding the learning and review process. The mobile app offers a seamless learning experience between your smartphone and the web with your memory profile maintained and managed in the cloud. UNIQUE! Your memory strength is profiled at the course, chapter, and item level to identify personal learning and forgetting patterns. UNIQUE! Material is re-presented just before you would naturally forget it to counteract memory decay. A personalized learning pathway is established based on your learning profile, memory map, and time required to demonstrate information mastery. The comprehensive student dashboard allows you to view your personal learning progress. |
| cimzia instructions for use: Moderate to Severe Psoriasis John Koo, Jashin Wu, Alice Gottlieb, Ethan Levin, Argentina Leon, 2014-03-18 Written by experts in the dermatology field, this new fourth edition of Moderate-to-Severe Psoriasis discusses the current use of biologics and other pharmacologic and phototherapy treatments for moderate-to-severe psoriasis. Illustrated with high quality color figures, this standalone text emphasizes safe and effective treatments for the psoriasis |
| cimzia instructions for use: Developing Drug Products in an Aging Society Sven Stegemann, 2016-10-20 This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies. |
| cimzia instructions for use: Pocket Guide to GastrointestinaI Drugs M. Michael Wolfe, Robert C. Lowe, 2014-01-02 Learn all you need to know about gastrointestinal drugs and their clinical use with this one-stop, rapid reference pocket guide. Brought to you by many of the world's leading GI drug experts, Pocket Guide to Gastrointestinal Drugs provides comprehensive guidance to the pharmacological properties of drugs used to treat gastrointestinal conditions, including mechanisms of action, appropriate administration, and potential adverse effects associated with their use. Organized by class of drug and ranging from PPIs to immunosupressants, each chapter first examines the specific agents within that class and then their appropriate and judicious use across a range of specific GI disorders. Key features include: Introduction of drug class Basic pharmacology, including mechanism of action, bioavailability, metabolism, interactions, adverse effects, toxicity, and special considerations Dosing information for each GI condition and on- and off-label use Consistent use of both generic and trade names throughout Specific reference to drug use in pediatric patients and during pregnancy Perfect for quick consultation on the wards and in the office, Pocket Guide to Gastrointestinal Drugs is the ideal tool for all those managing patients with GI conditions, including gastroenterologists, GI trainees, emergency physicians, GI specialist nurses, primary care physicians and residents, intensivists and pharmacists. |
| cimzia instructions for use: DC: 0-5 , 2016-11-01 |
| cimzia instructions for use: Development of Biopharmaceutical Drug-Device Products Feroz Jameel, John W. Skoug, Robert R. Nesbitt, 2020-03-13 The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field. |
| cimzia instructions for use: The Heart in Rheumatic, Autoimmune and Inflammatory Diseases Udi Nussinovitch, 2017-02-10 The prevalence of autoimmune diseases and rheumatic conditions is constantly increasing. Autoimmune diseases affect approximately 7-10% of the population of the United States, while more than 50,000,000 American adults suffer from some type of arthritis. The Heart in Rheumatic, Autoimmune and Inflammatory Diseases examines the complex mechanisms relating to cardiac diseases from a pathophysiological and clinical point of view. Autoimmune rheumatic diseases can affect the coronary vessels, myocardium, pericardium, heart valves and the conduction system. The diagnosis of these unique cardiac complications necessitates medical awareness and a high index of suspicion. Increased risk of advanced atherosclerosis plays a pivotal role in the development of cardiac diseases in systemic, rheumatic and autoimmune illnesses. Yet, other complex immune medicated mechanisms may contribute to the pathogenesis. Patients' optimal care requires coordination between the primary caregiver, the rheumatologist, immunologist and cardiologist. Screening for cardiovascular risk factors, recognition of high-risk patients and identification of subclinical cardiac conditions are of great importance. Moreover, regulation of inflammation, as well as abnormal immune responses and the initiation of early treatments should be the focus of patient management. A continuous attempt to identify novel therapeutic targets and change the natural history of the underlying disease and its cardiac manifestations is in progress. The book aims at providing the readers with a state of the art collection of up to date information regarding clinically important topics based on experts' perspectives. This book was a result of an extended coordinated collaboration of one-hundred and fifty-four distinguished scientists from thirty-one countries around the globe. - A review of common, as well as unusual (yet clinically significant) medical cardiac complications of prevalent rheumatic, autoimmune and inflammatory diseases. - Focuses on aspects of pathophysiological processes, clinical presentations, screening tests, prognostic implications and novel therapeutic approaches. - Presents an up-to-date level of evidence and strengths of recommendations for suggested therapies and reviews all randomized clinical trials, meta-analyses and other supporting published clinical findings. |
| cimzia instructions for use: Research of Pathogenesis and Novel Therapeutics in Arthritis Chih-Hsin Tang, 2019-06-04 Arthritis has a high prevalence globally and includes over 100 different types, the most common of which are rheumatoid arthritis, osteoarthritis, psoriatic arthritis, and inflammatory arthritis. The exact etiology of arthritis remains unclear and no cure exists. Anti-inflammatory drugs are commonly used in the treatment of arthritis but are associated with significant side effects. Novel modes of therapy and additional prognostic biomarkers are urgently needed for arthritis patients. This book summarizes and discusses the global picture of the current understanding of arthritis. |
| cimzia instructions for use: Havard's Nursing Guide to Drugs Adriana Tiziani, 2021-11-30 - Updates to all entries - New drugs including immunomodifying agents, antineoplastic agents and metabolic disorder agents - Guidance on drugs 'Not to be crushed' |
| cimzia instructions for use: The Lupus Encyclopedia Donald E. Thomas Jr., 2023-09-05 Now completely updated! The best-selling, most comprehensive guide to lupus, its complications, and management. Lupus is an autoimmune disease that can attack any body organ. It is three times more common in the United States today than it was in the 1980s, so there is an increased need for accurate, practical information on this potentially devastating disease. Lupus expert and clinician Donald E. Thomas, Jr., MD, provides all the helpful information patients need so they can understand and treat this disease. Highlighting amazing advancements in the diagnosis and treatment of lupus, this edition includes new and expanded information on: • The latest FDA-approved medications • How lupus affects different body parts • Advanced labs that improve lupus diagnosis and treatment • The role of the microbiome and anti-inflammatory diets • Updated recommendations for those who are pregnant or breastfeeding • Childhood-onset lupus • The interaction between COVID-19 and lupus • Non-drug treatments, complementary medicine, and medical cannabis The gold standard since it was first published and carefully reviewed by experts in the field, the latest edition of The Lupus Encyclopedia is essential for patients, health care providers, and families. Bonus content on insurance issues and information about working with lupus and disability is also available online. Endorsed by The Lupus Foundation of America Contributors: Jemima Albayda, MD; Divya Angra, MD; Alan N. Baer, MD; Sasha Bernatsky, MD, PhD; George Bertsias, MD, PhD; Ashira D. Blazer, MD; Ian Bruce, MD; Jill Buyon, MD; Yashaar Chaichian, MD; Maria Chou, MD; Sharon Christie, Esq; Angelique N. Collamer, MD; Ashté Collins, MD; Caitlin O. Cruz, MD; Mark M. Cruz, MD; Dana DiRenzo, MD; Jess D. Edison, MD; Titilola Falasinnu, PhD; Andrea Fava, MD; Cheri Frey, MD; Neda F. Gould, PhD; Nishant Gupta, MD; Sarthak Gupta, MD; Sarfaraz Hasni, MD; David Hunt, MD; Mariana J. Kaplan, MD; Alfred Kim, MD; Deborah Lyu Kim, DO; Rukmini Konatalapalli, MD; Fotios Koumpouras, MD; Vasileios C. Kyttaris, MD; Jerik Leung, MPH; Hector A. Medina, MD; Timothy Niewold, MD; Julie Nusbaum, MD; Ginette Okoye, MD; Sarah L. Patterson, MD; Ziv Paz, MD; Darryn Potosky, MD; Rachel C. Robbins, MD; Neha S. Shah, MD; Matthew A. Sherman, MD; Yevgeniy Sheyn, MD; Julia F. Simard, ScD; Jonathan Solomon, MD; Rodger Stitt, MD; George Stojan, MD; Sangeeta Sule, MD; Barbara Taylor, CPPM, CRHC; George Tsokos, MD; Ian Ward, MD; Emma Weeding, MD; Arthur Weinstein, MD; Sean A. Whelton, MD |
| cimzia instructions for use: Manual for Pharmacy Technicians Bonnie S. Bachenheimer, 2019-08-15 The Trusted Training Resource for Pharmacy Technicians at All Levels The role of pharmacy technicians is rapidly expanding, and demand for well-trained technicians has never been higher! Technicians are assuming more responsibilities and are taking on greater leadership roles. Quality training material is increasingly important for new technicians entering the field, and current technicians looking to advance. Look no further than the new 5th edition of the best-selling Manual for Pharmacy Technicians to master the practical skills and gain the foundational knowledge all technicians need to be successful. |
| cimzia instructions for use: Pharmacology of Immunotherapeutic Drugs Clinton B. Mathias, Jeremy P. McAleer, Doreen E. Szollosi, 2019-10-18 Medicine has entered a golden age in which therapeutic agents are becoming widely available due to advances in basic science and technology. As such, many drugs have been developed that target inflammatory processes and/or the immune system. This book is intended for health professionals examining the modulation of inflammation by immunotherapeutic drugs. The immune system fills the primordial role of host defense and resistance to infections with pathogenic microorganisms. Several hematopoietic-derived cells constituting the innate and adaptive immune systems cooperate to provide barriers for microbial colonization and/or promote pathogen destruction within the host. Conversely, many immune cells are also involved in the pathogenesis and propagation of chronic inflammatory diseases. The beginning of this book details various components of the immune system including the cell types, lymphoid tissues, soluble cytokines and surface molecules that are essential for host defense. Breakdowns in immune tolerance, or dysregulated immune responses to antigens derived from self tissues or innocuous sources, can lead to the development of autoimmunity or chronic inflammatory diseases. Pathophysiologic roles for the immune system are detailed in corresponding chapters on autoimmunity, epithelial surfaces (lungs, skin, intestine), and transplantation, with special emphasis placed on immunotherapeutic drug targets. The last section of the book focuses on treatments that stimulate our immune system to specifically target and fight infectious diseases and cancer. In each chapter, the medications used to treat various diseases/conditions in terms of their mechanism of action and other pharmacologic properties are detailed. Chapters begin with a table showing drug names and classifications. The importance of basic science and clinical trials cannot be understated in the context of drug development. As such, the discovery of certain medications that had a lasting impact in medicine and pharmacy are highlighted in chapter subsections named “Bench to Bedside.” Several clinical applications of immunotherapeutic drugs are described within end-of -chapter case studies including practice questions. The Pharmacology of Immunotherapeutic Drugs is a reference for immunologists and clinicians (medical doctors, pharmacists, nurses) examining the modulation of inflammatory processes by a variety of medications targeting the cells and mediators of our immune system. |
| cimzia instructions for use: Biologic and Systemic Agents in Dermatology Paul S. Yamauchi, 2018-01-02 Written by leading experts in the field and designed for dermatologists and residents, this book includes evidence-based medicine that underscores the clinical data, as well as practical tips on how to use both biologic and systemic agents in the field of dermatology. In the past decade, there have been several groundbreaking advances in medical dermatology. Novel biologic and systemic agents have been developed to treat inflammatory disorders, including psoriasis and atopic dermatitis, as well as skin malignancies such as melanoma. Biologic and Systemic Agents in Dermatology encompasses these developments by describing the mechanism of action of these various agents and the clinical efficacy and safety to treating these respective disorders. The utilization of biologic and systemic agents in other dermatologic conditions, pharmacoeconomics, pharmacovigilance, and clinical trials outcomes are discussed as well as topics including tumor necrosis, conventional systemic agents for psoriatic disease, and oral agents for atopic dermatitis. |
| cimzia instructions for use: Immunologic Concepts in Transfusion Medicine Robert W Maitta, 2019-08-27 Immunological Concepts in Transfusion Medicine provides a thorough discussion of the immune aspects of blood component transfusion, with in-depth information on the intricacies of immune responses to blood components and the immune processes that may be initiated in response to blood exposure. Written to increase knowledge and awareness of immune challenges such as alloimmunization and transfusion-related acute lung injury, this title bridges current basic scientific discoveries and the potential effects seen in blood recipients. - Complies the knowledge and expertise of Dr. Robert Maitta, an expert in immune responses and antibody function/structure studies. - Helps clinicians in the daily practice of caring for patients in need of transfusion support, as well as physicians in training when considering utilizing blood transfusions in a limited scope or in the setting of massive transfusion. - Includes an immunology primer as an introduction to in-depth chapters covering allergic immune reactions to blood components, transfusion-related immunomodulation, fetal and neonatal alloimmune thrombocytopenia and neonatal neuthropenia, complications of haploidentical and mismatched HSC transplantation, chimeric antibody receptor therapies, and much more. - Consolidates today's available information on this timely topic into a single, convenient resource. |
| cimzia instructions for use: Breastfeeding and Medication Wendy Jones, 2018-05-11 Sadly, women often feel they have no alternative but to give up breastfeeding, having been prescribed or purchased medication. In many cases, however, this is unnecessary. This book outlines the evidence base for the use of medication during breastfeeding. Breastfeeding and Medication presents a comprehensive A to Z guide to the most frequently prescribed drugs and their safety for breastfeeding mothers. Evaluating the evidence for interventions and using a simple format for quickly identifying medications that are safe or unsafe to use, it also highlights those drugs where there is inconclusive evidence. Additional contextual information makes this the most complete text for those practitioners who support and treat breastfeeding women. It: provides an overview of the anatomy and physiology of the breast together with hormonal influences to better understand how complications, such as mastitis, arise and inform the approach to their treatment; includes a section on conditions that affect women specifically when they are lactating where prescription of medication may be necessary; discusses the importance of breastfeeding and its advantages, as well as its disadvantages; and explores how to support breastfeeding mothers, and presents a counselling model approach. This new edition contains information on more drugs and a chapter on the management of some chronic conditions which may affect breastfeeding mothers. In most cases there are options to support the mother’s optimal care whilst allowing her to continue to breastfeed her baby as long as she wishes. This is a topic which raises many questions on social media, which informed the choice of conditions to consider. This is an invaluable reference for all health practitioners and volunteers who work with, support and treat breastfeeding women, including lactation consultants, breastfeeding support workers, health visitors, GPs, practice nurses, pharmacists and midwives. |
| cimzia instructions for use: The Digitization of Healthcare Loick Menvielle, Anne-Françoise Audrain-Pontevia, William Menvielle, 2017-08-11 Combining conceptual, pragmatic and operational approaches, this edited collection addresses the demand for knowledge and understanding of IT in the healthcare sector. With new technology outbreaks, our vision of healthcare has been drastically changed, switching from a ‘traditional’ path to a digitalized one. Providing an overview of the role of IT in the healthcare sector, The Digitization of Healthcare illustrates the potential benefits and challenges for all those involved in delivering care to the patient. The incursion of IT has disrupted the value chain and changed business models for companies working in the health sector, and also raised ethical issues and new paradigms about delivering care. This book illustrates the rise of patient empowerment through the development of patient communities such as PatientLikeMe, and medical collaborate platforms such as DockCheck, thus providing a necessary tool to patients, caregivers and academics alike. |
| cimzia instructions for use: Textbook of Pediatric Rheumatology Ross E. Petty, 2005 Clinical reference designed to aid in the care of children with rheumatic diseases. Offers guidelines for interpreting the signs, symptoms and laboratory abnormalities that accompany these disorders. Includes numerous halftone illustrations and tables, radiographs, and other figures. |
| cimzia instructions for use: Drug Information Handbook Charles F. Lacy, Lora L. Armstrong, Morton P. Goldman, 2003 |
| cimzia instructions for use: Life Sciences Industry Basanta Kumara Bahera, Ram Prasad, Shyambhavee Behera, 2021-08-24 Basic principles of applied life sciences such as recombinant DNA technology is used in most life sciences industries marketing bio-formulations for designing more effective protein-based drugs, such as erythropoietin and fast-acting insulin etc. In recent times genetically engineered host cells from mammal, animal and plants are also being used in life sciences industries to manufacture biologics. This book discusses the most basic as well advanced issues on biological products for successfully managing a life sciences industry. It elucidates the life cycle of biological molecules, right from the conceptual development of different types of biopolymers, and their subsequent transfer from the conical flasks in laboratory to life sciences industries for large scale production and marketing. It focuses on sustainable longevity in the life cycle of commercial biopolymers. Cumulative facts and figures in this volume would immensely help in inspiring life sciences industry promoters to monitor value chain transfer process of biologics for better profitability. Additionally, it would serve as a perusal document for the students and researchers interested in entrepreneurial ventures or having their own start-up projects for the commercialization of biologics. |
| cimzia instructions for use: Antibody Engineering Volume 2 Roland E. Kontermann, Stefan Dübel, 2010-03-10 Antibodies are indispensable tools for research, diagnosis, and therapy. Recombinant approaches allow the modification and improvement of nearly all antibody properties, such as affinity, valency, specificity, stability, serum half-life, effector functions, and immunogenicity. Antibody Engineering provides a comprehensive toolbox covering the well-established basics but also many exciting new techniques. The protocols reflect the latest hands on knowledge of key laboratories in this still fast-moving field. Newcomers will benefit from the proven step-by-step protocols, which include helpful practical advice; experienced antibody engineers will appreciate the new ideas and approaches. The book is an invaluable resource for all those engaged in antibody research and development. |
| cimzia instructions for use: Immune Rebalancing Diana Boraschi, Giselle Penton-Rol, 2016-01-25 Immune Rebalancing: The Future of Immunosuppression summarizes the most promising perspectives of immunopharmacology, in particular in the area of immunosuppression by considering molecular pathways, personalized medicine, microbiome and nanomedicine. Modulation of immune responses for therapeutic purposes is a particularly relevant area, given the central role of anomalous immunity in diseases. These diseases vary from the most typically immune-related syndromes (autoimmune diseases, allergy and asthma, immunodeficiencies) to those in which altered immunity and inflammation define the pathological outcomes (chronic infections, tumours, chronic inflammatory and degenerative diseases, metabolic disorders, etc. - Visits immunosuppression from a modern point of view of signalling mechanisms at the light of the current knowledge of signalling mechanisms and regulatory networks allows the reader to formulate new ideas and concepts on how to use immunosuppression the therapeutic purposes - Encourages researchers to engage into exploring the field of pharmacological modulation of immune responses in depth, and with the new knowledge and tools available, designs more effective therapeutic strategies to autoimmune and inflammatory diseases, cancer, degenerative diseases and infections - Examines the link between molecular pathways associated to immune-suppression and the new immunopharmacology approaches - Provides information on the new strategies for drug development in this field - Considers the role of microbes in the development of the mammalian immune system and immune responses, which will widen the reader's strategy for addressing therapeutic immune modulations |
| cimzia instructions for use: Buck's 2020 HCPCS Level II E-Book Elsevier, 2019 |
| cimzia instructions for use: Chronic Graft Versus Host Disease Georgia B. Vogelsang, Steven Z. Pavletic, 2009-04-20 Chronic graft versus host disease (GVHD) is the most common complication of allogenic bone marrow transplantation. Because of the protracted clinical course of chronic GVHD, transplant centers and hematology/oncology offices are inadequately equipped to manage these immuno-incompetent patients with a multi-system disorder. Practitioners need to be able to recognize and effectively manage chronic GVHD as a late effect of more than half of allogenic transplantations. The text is oriented for the clinician, with chapters covering staging, organ site and system-specific manifestations, treatment options, and supportive care. Drs Georgia B. Vogelsang and Steven Z. Pavletic have been pioneers in the recognition of the multi-organ complexity of this disease and have gathered the input of a variety of subspecialist physicians for this book. This book fills the gap in practical literature on chronic GVHD, providing a comprehensive, up-to-date, and clinically relevant resource for anyone who deals with cancer patients post-transplant. |
| cimzia instructions for use: Braddom's Physical Medicine and Rehabilitation David X. Cifu, MD, 2015-08-20 The most-trusted resource for physiatry knowledge and techniques, Braddom's Physical Medicine and Rehabilitation remains an essential guide for the entire rehabilitation team. With proven science and comprehensive guidance, this medical reference book addresses a range of topics to offer every patient maximum pain relief and optimal return to function. In-depth coverage of the indications for and limitations of axial and peripheral joints through therapies enables mastery of these techniques. Optimize the use of ultrasound in diagnosis and treatment. A chapter covering PM&R in the international community serves to broaden your perspective in the field. Detailed illustrations allow you to gain a clear visual understanding of important concepts. New lead editor - Dr. David Cifu - was selected by Dr. Randall Braddom to retain a consistent and readable format. Additional new authors and editors provide a fresh perspective to this edition. Features comprehensive coverage of the treatment of concussions and military amputees. Includes brand-new information on rehabilitating wounded military personnel, the latest injection techniques, speech/swallowing disorders, head injury rehabilitation, and the rehabilitation of chronic diseases. New chapters on pelvic floor disorders and sensory impairments keep you at the forefront of the field. Reader-friendly design features an updated table of contents and improved chapter approach for an enhanced user experience. Expert Consult eBook version included with purchase. This enhanced eBook experience gives access to the text, figures, over 2,500 references, 51 videos, and 750 self-assessment questions on a variety of devices. |
| cimzia instructions for use: Implantable Drug Delivery Systems Urban Laffer, Irène Bachmann-Mettler, Urs Metzger, 1991 |
| cimzia instructions for use: 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. |
| cimzia instructions for use: Drug Discovery in Japan Sadao Nagaoka, 2019-10-24 This book analyzes the drug-discovery process in Japan, based on detailed case studies of 12 groups of 15 innovative drugs. It covers the first statin in the world up to the recent major breakthrough in cancer therapy, the recent immune checkpoint inhibitor, the scientific discovery for which a 2018 Nobel Prize in Physiology or Medicine was awarded to Prof. Tasuku Honjo, Kyoto University. The book shows the pervasive high uncertainty in drug discovery: frequent occurrences of unexpected difficulties, discontinuations, serendipities, and good luck, significantly because drug discovery starts when the underlying science is incomplete. Thus, there exist dynamic interactions between scientific progress and drug discovery. High uncertainty also makes the value of an entrepreneurial scientist high. Such scientists fill the knowledge gaps by absorbing external scientific progress and by relentless pursuit of possibilities through their own research, often including unauthorized research, to overcome crises. Further, high uncertainty and its resolution significantly characterize the evolution of competition in the drug industry. The patent system promotes innovation under high uncertainty not only by enhancing appropriability of R&D investment but also by facilitating the combination of knowledge and capabilities among different firms through disclosure. Understanding such a process significantly benefits the creation of innovation management and policy practices. |
| cimzia instructions for use: Selective COX-2 Inhibitors Sir John R. Vane, Jack H. Botting, 2012-12-06 The mainstay of therapy for rheumatoid disease is the non-steroid antiinflammatory drugs (NSAIDs), despite their inherent gastrointestinal toxicity and ability to cause renal damage in susceptible patients. The theory that the beneficial and toxic effects of NSAIDs stem from a reduction in prostanoid production through inhibition of cyclooxygenase implied that particular toxicities were inevitable with NSAIDs and would always be correlated with efficacy. However, over the years, it became apparent that at therapeutic doses, some NSAIDs had greater toxic side-effects than others, a fact not explained by the general theory. A significant clarification arose from the discovery that there are two distinct isoforms of COX, a constitutive enzyme (COX-I) responsible for the production of prostanoids necessary for platelet aggregation and protection of the gastric mucosa and kidney; and an inducible enzyme (COX-2) that is newly synthesized at sites of tissue damage and produces prostaglandins that manifest pathological effects. It became clear that different NSAIDs had greater or lesser effects on COX-I when used in therapeutic doses, explaining the variation in side-effects. ' The elucidation of the crystal structure of these different enzymes and the skills of medicinal chemists have led to the synthesis of new chemicals with a selectivity for the inducible enzyme, and thus with therapeutic efficacy without those toxic effects result ing from inhibition of the constitutive enzyme. |
CIMZIA® (certolizumab pegol) | An FDA-Approved Biologic …
What is CIMZIA? CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease …
How CIMZIA® Works for Moderate-to-Severe Rheumatoid Arthritis
What is CIMZIA? CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease …
Dosing and Administration | CIMZIA® (certolizumab pegol)
Learn how to take CIMZIA® including dosage and administration schedule. See full Prescribing Information including boxed warning on serious infections. Full Prescribing and Patient …
MEDICATION GUIDE - CIMZIA
CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used in adults to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease (CD) in …
HIGHLIGHTS OF PRESCRIBING INFORMATION These …
CIMZIA is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an …
Self-Inject with the prefilled syringe - CIMZIA
Review CIMZIA® (certolizumab pegol) guides for self-injection at home. See full Prescribing Information including boxed warning on serious infections. Full Prescribing and Patient …
CIMZIA® for Moderate-to-Severe Rheumatoid Arthritis
What is CIMZIA? CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease …
CIMplicity® Registration - CIMZIA
What is CIMZIA? CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease …
The CIMplicity Savings Program - CIMZIA
Eligible, commercially insured patients with approved coverage may receive CIMZIA® for as little as $0 per dose. See full PI including boxed warning.
CIMZIA® CIMplicity Savings Program and Support
CIMZIA is approved for the treatment of adults with active ankylosing spondylitis (AS). CIMZIA is approved to lessen the signs and symptoms of moderately to severely active Crohn’s disease …
CIMZIA® (certolizumab pegol) | An FDA-Approved Biologic …
What is CIMZIA? CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease …
How CIMZIA® Works for Moderate-to-Severe Rheumatoid Arthritis
What is CIMZIA? CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease …
Dosing and Administration | CIMZIA® (certolizumab pegol)
Learn how to take CIMZIA® including dosage and administration schedule. See full Prescribing Information including boxed warning on serious infections. Full Prescribing and Patient …
MEDICATION GUIDE - CIMZIA
CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used in adults to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease (CD) in …
HIGHLIGHTS OF PRESCRIBING INFORMATION These …
CIMZIA is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an …
Self-Inject with the prefilled syringe - CIMZIA
Review CIMZIA® (certolizumab pegol) guides for self-injection at home. See full Prescribing Information including boxed warning on serious infections. Full Prescribing and Patient …
CIMZIA® for Moderate-to-Severe Rheumatoid Arthritis
What is CIMZIA? CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease …
CIMplicity® Registration - CIMZIA
What is CIMZIA? CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease …
The CIMplicity Savings Program - CIMZIA
Eligible, commercially insured patients with approved coverage may receive CIMZIA® for as little as $0 per dose. See full PI including boxed warning.
CIMZIA® CIMplicity Savings Program and Support
CIMZIA is approved for the treatment of adults with active ankylosing spondylitis (AS). CIMZIA is approved to lessen the signs and symptoms of moderately to severely active Crohn’s disease …
