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 Non Biological Complex Drugs written by Daan J.A. Crommelin and published by Springer. This book was released on 2015-06-24 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.

Download or read book Introduction to Biological and Small Molecule Drug Research and Development written by C. Robin Ganellin and published by Academic Press. This book was released on 2013-05-07 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to Biological and Small Molecule Drug Research and Development provides, for the first time, an introduction to the science behind successful pharmaceutical research and development programs. The book explains basic principles, then compares and contrasts approaches to both biopharmaceuticals (proteins) and small molecule drugs, presenting an overview of the business and management issues of these approaches. The latter part of the book provides carefully selected real-life case studies illustrating how the theory presented in the first part of the book is actually put into practice. Studies include Herceptin/T-DM1, erythropoietin (Epogen/Eprex/NeoRecormon), anti-HIV protease inhibitor Darunavir, and more. Introduction to Biological and Small Molecule Drug Research and Development is intended for late-stage undergraduates or postgraduates studying chemistry (at the biology interface), biochemistry, medicine, pharmacy, medicine, or allied subjects. The book is also useful in a wide variety of science degree courses, in post-graduate taught material (Masters and PhD), and as basic background reading for scientists in the pharmaceutical industry. For the first time, the fundamental scientific principles of biopharmaceuticals and small molecule chemotherapeutics are discussed side-by-side at a basic level Edited by three senior scientists with over 100 years of experience in drug research who have compiled the best scientific comparison of small molecule and biopharmaceuticals approaches to new drugs Illustrated with key examples of important drugs that exemplify the basic principles of pharmaceutical drug research and development

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 FDA Approved Animal Drug Products written by and published by . This book was released on 1998 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Analysis of Drugs in Biological Fluids written by Joseph Chamberlain and published by CRC Press. This book was released on 2018-02-06 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition focuses on a variety of techniques available for the analysis of drugs in biological fluids. Over 150 figures and tables help to describe the latest advances and give examples of their applications. Current chiral analysis methods as well as discussions on the impact of chirality are described. Practical aspects of bioanalytical work, including many examples of laboratory problems not often reported in the scientific literature, are examined in depth.

Download or read book Mind Fixers Psychiatry s Troubled Search for the Biology of Mental Illness written by Anne Harrington and published by W. W. Norton & Company. This book was released on 2019-04-16 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mind Fixers tells the history of psychiatry’s quest to understand the biological basis of mental illness and asks where we need to go from here. In Mind Fixers, Anne Harrington, author of The Cure Within, explores psychiatry’s repeatedly frustrated struggle to understand mental disorder in biomedical terms. She shows how the stalling of early twentieth century efforts in this direction allowed Freudians and social scientists to insist, with some justification, that they had better ways of analyzing and fixing minds. But when the Freudians overreached, they drove psychiatry into a state of crisis that a new “biological revolution” was meant to alleviate. Harrington shows how little that biological revolution had to do with breakthroughs in science, and why the field has fallen into a state of crisis in our own time. Mind Fixers makes clear that psychiatry’s waxing and waning biological enthusiasms have been shaped not just by developments in the clinic and lab, but also by a surprising range of social factors, including immigration, warfare, grassroots activism, and assumptions about race and gender. Government programs designed to empty the state mental hospitals, acrid rivalries between different factions in the field, industry profit mongering, consumerism, and an uncritical media have all contributed to the story as well. In focusing particularly on the search for the biological roots of schizophrenia, depression, and bipolar disorder, Harrington underscores the high human stakes for the millions of people who have sought medical answers for their mental suffering. This is not just a story about doctors and scientists, but about countless ordinary people and their loved ones. A clear-eyed, evenhanded, and yet passionate tour de force, Mind Fixers recounts the past and present struggle to make mental illness a biological problem in order to lay the groundwork for creating a better future, both for those who suffer and for those whose job it is to care for them.

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 Biologics and Biosimilars written by Xiaodong Feng and published by CRC Press. This book was released on 2022-06-13 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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 New Natural Products and Plant Drugs with Pharmacological Biological or Therapeutical Activity written by H.K. Wagner and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fact that, of the approximately 600,000 plant species existing on the earth, only some 5 % have been specifically investigated chemically or pharmacologi cally, is a challenge to chemists spezializing in na tural substances and to pharmacologists. In view of the limited number of research capacities and the ever diminishing financial means, this challenge can only be met if, together with an improvement and refinement of methods of analysis, medicinal plant research is carried out on a broader interdisciplinary basis, with comparable, scientifically recognized screening methods, and if it is better coordinated, with greater use of modern documentation means. It is thus necessary in the future to concentrate specifically on projects leading to the development of new medicinal prepara tions. The plenary lectures hold in the present symposium of the 1st International Congress for Research on Medi cinal Plants reflect these efforts and tendencies. At the same time they provide a survey of some of the fields of medicinal plant research which are at present most actual and most intensively researched. They range from plant screening, isolation and structure eluci dation of new principles, to the therapeutical opti mization of a natural product. The lectures given at this congress show clearly the necessity, in addition to national phytochemical so cieties, for a central international organisation, in which all active medicinal plant researchers in the world are included. Their aim should be to provide the impulse for more optimal, rational research, aimed at the solution of specific projects.

Download or read book Biotechnology and Biopharmaceuticals written by and published by John Wiley & Sons. This book was released on 2013-09-19 with total page 744 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Download or read book Preparation Technology and Pharmacology of Biological Drugs written by Cheng-Hao Jin and published by Scientific Research Publishing, Inc. USA. This book was released on 2021-04-07 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on modern life science, biological drugs combine advanced engineering technology and scientific principles of other basic disciplines, and transform organisms or process biological raw materials according to leading designs. Biopharmaceutical raw materials are mainly natural biological materials, including microorganisms, human body, animals, plants, Marine organisms and so on. With the development of biotechnology, purposeful artificial biological raw materials have become the main source of biopharmaceutical raw materials. Biological drugs are characterized by high pharmacological activity, small toxic and side effects and high nutritional value. Biological drugs mainly include proteins, nucleic acids, carbohydrates, lipids and so on. The constituent units of these substances are amino acids, nucleotides, monosaccharides, fatty acids, etc., which are not only harmless to the human body but also important nutrients.

Download or read book Regulation of Biological Products written by National Institutes of Health (U.S.). Division of Biologics Standard and published by . This book was released on 1960 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 610 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 Fast Facts Biosimilars in Hematology and Oncology written by P. Cornes and published by Karger Medical and Scientific Publishers. This book was released on 2020-01-24 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biologics have revolutionized – and are revolutionizing – the treatment of many serious disorders. The evidence acquired from more than 10 years of clinical experience, with more than 50 biosimilar drugs and more than 700 million patient-days' exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. Yet concerns persist about biosimilars – particularly in curative cancer treatment, where they are relatively recent therapeutic options. 'Fast Facts: Biosimilars in Hematology and Oncology' provides a concise overview of emerging global practice in this fast-moving area together with practical information on adding biosimilars to a formulary and switching patients. Contents: • Biologics and the need for biosimilars • Why do we need biosimilars? • How is the quality of biosimilar medicines assured? • Legal issues • Switching, interchangeability and extrapolation • Safety and pharmacovigilant • Global issues • Formulary considerations: pharmacy issues • Formulary considerations: supportive care biosimilars • Formulary considerations: therapeutic anti-cancer biosimilars • Communication and awareness

Download or read book The Analysis of Drugs in Biological Fluids written by Joseph Chamberlain and published by CRC Press. This book was released on 2018-02-06 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition focuses on a variety of techniques available for the analysis of drugs in biological fluids. Over 150 figures and tables help to describe the latest advances and give examples of their applications. Current chiral analysis methods as well as discussions on the impact of chirality are described. Practical aspects of bioanalytical work, including many examples of laboratory problems not often reported in the scientific literature, are examined in depth.