This is the first book to cover every angle in the clinical application of biologics. Readers will not only find that all of the biologics currently approved for clinical use are delineated in a standardized way, but also the "differential therapy" with biologics in fields including dermatology and neurology is described in detail and summarized in treatment algorithms. Shorter sections on biologic biotechnology as well as safety and regulatory issues complement the more clinically-oriented central chapters.
A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
A drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process. Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. A biosimilar is a biologic that is similar to another biologic drug already that has already been approved. This book is a complete guide to the use of biologics and biosimilars in the treatment of dermatologic disorders. Beginning with an overview of the history and classification of biologics and the concept of biosimilars, the following chapters explain their therapeutic use for different skin conditions. The final sections cover related topics such as cost effectiveness and quality of life with biologic therapy, and the book concludes with discussion on future developments and the use of small molecule treatment. Key points Complete guide to use of biologics and biosimilars in treatment of dermatologic disorders Covers many different skin diseases and conditions Discusses related topics such as cost effectiveness and quality of life Covers future development of small molecule therapy
Biologics have revolutionized the treatment of autoimmune diseases due to their efficacy, speed of onset, and tolerability. The development of new agents and expanded use of existing agents continues to be a highly active area of investigation among rheumatic diseases, with a multitude of innovative therapeutic strategies in various stages of development. Although the story of treatments continues rapidly, therapeutic research in some conditions is hindered by the rarity of the disease, variation in phenotype, and concerns about toxicity. This fast-paced development of therapeutics,necessitates immediate evaluation of individual biologic agents and their best use in the new treatment regimens./div This book provides an inclusive approach with the existing evidence concerning effectiveness and implications on the usage of biologics in treating various rheumatologic disorders. It also covers the evidence behind the rational use of these agents in varied autoimmune diseases. This manual also offers a complete overview of the existing & futuristic biologic treatments, and draws recommendations on how to standardize the most suitable regimen for a specific patient in the context of current guidelines. The handbook of Biologics in Rheumatology serves as a present and concise compendium to the modern therapeutic developments in the field./div This book is likely to benefit clinicians, residents, fellow and other healthcare workers dealing with rheumatological disorders, and also hard-core Rheumatologists, who are looking for a quick recap of Biologics of their interest. /div
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
The use of biologics – drugs made from living organisms – has raised specific scientific, industrial, medical and legal issues. The essays contained in this collection each deal with a case study of a biologic substance, or group of biologics, and its use during the twentieth century.
This is the first book to cover every angle in the clinical application of biologics. Readers will not only find that all of the biologics currently approved for clinical use are delineated in a standardized way, but also the "differential therapy" with biologics in fields including dermatology and neurology is described in detail and summarized in treatment algorithms. Shorter sections on biologic biotechnology as well as safety and regulatory issues complement the more clinically-oriented central chapters.
This book is a scientific compendium documenting the state of the art in the discovery and development of vaccines, monoclonal antibodies, and enzymes for the treatment of Substance Use Disorders (SUDs). The book gives detailed consideration to some of the most cutting edge topics in addiction medicine, including vaccines for nicotine, cocaine, heroin, and methamphetamine dependence; monoclonal antibodies against cocaine, methamphetamine, and phencyclidine; and the enzymes butyrylcholinesterase and cocaine esterase. In addition, the text covers a wide range of new strategies designed to optimize the development and efficacy of biologics. Unlike any other resource, this book reviews how biologics offer exciting new therapeutic opportunities for various psychiatric conditions. Written by experts in the field, Biologics to Treat Substance Use Disorders is as an authoritative reference for psychiatrists, psychologists, and all other medical professionals working with patients suffering from Substance Use Disorders.
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.
