Safety of Biologics Therapy


Book Description

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.







Safe and Effective Medicines for Children


Book Description

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.




Rare Diseases and Orphan Products


Book Description

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.




Rheumatoid Arthritis


Book Description

Emphasizes the importance of early intervention in RA with focus on pharmacologic treatment of RA. Detailed information on the various medications employed in treatment, including corticosteroids, NSAIDs DMARDs, biologic agents, and combination therapy is reviewed, including evidence based data on efficacy, safety, side effects, and monitoring requirements. Clinical evaluation is presented, including lab findings, joint scoring, diagnostic criteria, and radiographic outcomes. Surgical options and the management of advanced RA are disussed.







Immunologic Concepts in Transfusion Medicine


Book Description

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.




Cancer and Autoimmunity


Book Description

Of the two disciplines in parallel development for two decades, tumor immunology and transplantation immunology, the latter has thrived and has led to some of the most critical discoveries in immunobiology. The former continues to thwart both scientists and clinicians alike.The goal of immunologists in modern day research is to develop a simple and effective means to manipulate cancer in vivo, possibly encompassing several venues: identifying a phenotypic marker and the use of either active or passive immunization; include the use of passive reagents carrying "warheads" to selectively destroy cancer cells; or altering the basic process of cell survival.This excellent multidiscipline-authored volume presents a theme which has not been well described before. The papers include both basic and clinical science and range from sophisticated molecular biology to little more than phenomenology (e.g. the increased association of cancer in some autoimmune diseases and increased presentation of autoimmune phenomena in malignant condition). This, however, is state-of-the-art.This collection of themes will be of use not only to bench scientists, but also to clinicians who treat patients. The book represents progress at the cutting edge of this discipline, and points the way to further developments in the "black box" of immunology.







Anticancer Drugs


Book Description

The past decades have seen major developments in the understanding of the cellular and molecular biology of cancer. Significant progress has been achieved regarding long-term survival for the patients of many cancers with the use of tamoxifen for treatment of breast cancer, treatment of chronic myeloid leukaemia with imatinib, and the success of biological drugs. The transition from cytotoxic chemotherapy to targeted cancer drug discovery and development has resulted in an increasing selection of tools available to oncologists. In this Special Issue of Pharmaceuticals, we highlight the opportunities and challenges in the discovery and design of innovative cancer therapies, novel small-molecule cancer drugs and antibody–drug conjugates, with articles covering a variety of anticancer therapies and potential relevant disease states and applications. Significant efforts are being made to develop and improve cancer treatments and to translate basic research findings into clinical use, resulting in improvements in survival rates and quality of life for cancer patients. We demonstrate the possibilities and scope for future research in these areas and also highlight the challenges faced by scientists in the area of anticancer drug development leading to improved targeted treatments and better survival rates for cancer patients.