Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Biologics in General Medicine written by W.-H. Boehncke and published by Springer Science & Business Media. This book was released on 2007-08-09 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics written by Lisa M.. Plitnick and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biologics in General Medicine written by W.-H. Boehncke and published by Springer Science & Business Media. This book was released on 2007-05-08 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Biologics Biosimilars and Biobetters written by Iqbal Ramzan and published by John Wiley & Sons. This book was released on 2021-02-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Biologics A History of Agents Made From Living Organisms in the Twentieth Century written by Alexander von Schwerin and published by Routledge. This book was released on 2015-10-06 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Biologics for the Treatment of Rheumatoid Arthritis written by Ronald van Vollenhoven and published by Adis. This book was released on 2016-01-06 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive overview of the available biologic therapies whilst comparing them to standard disease modifying anti-rheumatic drugs, and discusses how best to determine which therapy is most appropriate for an individual patient in the framework of current guidelines. Biologics for the Treatment of Rheumatoid Arthritis is an up-to-date and concise practical guide to the latest therapeutic developments in this field. This book is an invaluable source of topical information for all rheumatologists and health care professionals treating patients with rheumatoid arthritis.
Download or read book Drug Drug Interactions for Therapeutic Biologics written by Honghui Zhou and published by John Wiley & Sons. This book was released on 2013-05-10 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics.
Download or read book Safety of Biologics Therapy written by Brian A. Baldo and published by Springer. This book was released on 2016-08-12 with total page 623 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Biological Drug Products written by Wei Wang and published by John Wiley & Sons. This book was released on 2013-08-29 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
Download or read book Orthobiologics written by Giuseppe Filardo and published by Springer Nature. This book was released on 2021-12-02 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents the evidence related to the use of injectable biologics to provide faster and better healing for musculoskeletal lesions and conditions. The authors discuss approaches, such as blood derivatives and cell concentrates, applied to lesions of muscles, ligaments, tendons, bones, meniscus and cartilage, as well as osteoarthritis. Chapters are written by some of the most influential opinion leaders in the field, with up-to-date review of the current literature, where the authors explore both the potential and the limitations of these minimally invasive and promising treatments. The first section is devoted to the formulations and rationale for the use of injectable orthobiologics, while the second section reviews current treatment methods applied to specific joints and pathologies – ranging from tendinopathies through non-unions to articular degenerative processes – as well as the results of these treatment approaches. The third section explores future perspectives, such as pluripotent stem cells, gene therapy, and the stimulation of intrinsic stromal cell niches. Appealing to a broad readership, this book will be of interest to both laboratory research scientists and clinicians, including orthopedists, sports physicians, physiatrists, and regenerative medicine experts.
Download or read book Targeted Regulatory Writing Techniques Clinical Documents for Drugs and Biologics written by Linda Fossati Wood and published by Springer Science & Business Media. This book was released on 2009-01-05 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.
Download or read book Supply Chain Management in the Drug Industry written by Hedley Rees and published by John Wiley & Sons. This book was released on 2011-04-06 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.
Download or read book Translational Medicine written by Joy A. Cavagnaro and published by CRC Press. This book was released on 2021-11-26 with total page 952 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
Download or read book Biologics in Rheumatology written by Coziana Ciurtin and published by . This book was released on 2016 with total page 539 pages. Available in PDF, EPUB and Kindle. Book excerpt: Significant progress has been acquired in the treatment of rheumatic conditions with the introduction of biologic therapies, which has enabled better control of disease activity and improved patients' long-term outcome. Apart from several biologic treatments already licensed for use in autoimmune rheumatic conditions, numerous other agents are currently under investigation. This rapid expansion of the therapeutic armamentarium requires a critical analysis of individual biologic options and their clinical indications, in order to facilitate the optimal use of these new therapies. The authors felt that a comprehensive book revisiting all the evidence available regarding the efficacy, cost-effectiveness and health implications of the use of biologics in rheumatology was needed in order to integrate the clinical, ethical and socio-economic aspects related to their use. This book is aimed at specialist doctors, trainees, nurses and health professionals working in the field of rheumatology. It critically appraises the level of evidence behind the use of biologic agents in diverse autoimmune diseases, comprising separate chapters which focus on rheumatoid arthritis, systemic lupus erythematosus, myositis, systemic sclerosis, Sjogren's syndrome, seronegative spondyloarthropathies, psoriatic arthritis and psoriasis, small, medium and large vessel vasculitis, osteoporosis, and interstitial lung disease associated with rheumatic conditions. In addition, the book explores aspects related to the use of biologic agents, such as ethical considerations of consenting patients to take part in clinical trials with biologics, and adolescent and adult rheumatology nurse perspectives related to patients' benefits of biologic therapies. Particular interest is given to the use of biologics during pregnancy and assessment of their infectious risks. A separate chapter explores the off-target benefits associated with the use of anti-TNF therapies. Several chapters include data about cost-effectiveness, and national and international guidelines for the use of biologic agents in different rheumatic conditions.
Download or read book Biologic and Systemic Agents in Dermatology written by Paul S. Yamauchi and published by Springer. This book was released on 2018-01-02 with total page 567 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
