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Biologics, A History of Agents Made From Living Organisms in the Twentieth Century
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.
Rare Diseases and Orphan Products
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.
Safe and Effective Medicines for Children
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.
Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws a...
Animal Cell Technology: Developments towards the 21st Century
Animal cell technology is a discipline of growing importance, which aims not merely at understanding structure, function and behaviour of differentiated animal cells, but especially at the development of their abilities useful for clinical application. Topics of interest in this regard include: viral vaccines, pharmaceutical proteins and novel applications such as gene therapy and organ culture. Undoubtedly, these Proceedings of the joint Meeting of the European Society for Animal Cell Technology and the Japanese Association for Animal Cell Technology (Veldhoven, The Netherlands, September 1994) review the most recent status of the field, and will be most valuable to anyone actively involved...
Treatment of Inflammatory Bowel Disease with Biologics
This book is a concise yet comprehensive overview of the use of biologics for the treatment of Crohn’s disease and ulcerative colitis. The volume details how best to utilize these medications in order to optimize their efficacy and safety, as well as how to understand, recognize, and treat complications that may arise from using biologics to treat IBD. The text also focuses on new data, novel biologics, and biosimilars of this rapidly expanding field. Written by experts in the field, Treatment of Inflammatory Bowel Disease with Biologics is a valuable resource for gastroenterologists, allied health professionals, fellows, and trainees who treat patients with inflammatory bowel disease.
Pharmacoepidemiology
This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
Adverse Reactions to Biologics
In many areas of medicine physicians still face the great challenge of finding therapies that will meet the patients’ needs. In dermatology the challenge has arisen on multiple fronts through advances in the understanding of the immunopathogenesis of many inflammatory and malignant cutaneous disorders. Breakthroughs, combined with significant developments in targeted immunotherapy, have resulted in improved outcomes as these newer therapies are being used for both approved indications and as off-label therapies for various chronic inflammatory skin disorders and many forms of skin cancer. In the expectation that by truly understanding the safety profile of these targeted therapies patients...
