Medicine And Biopharmaceutical
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Biotechnology And Biopharmaceuticals
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Author : Rodney J. Y. Ho
language : en
Publisher: John Wiley & Sons
Release Date : 2004-09-21
Biotechnology And Biopharmaceuticals written by Rodney J. Y. Ho and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-09-21 with Science categories.
Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs defines biotechnology from the perspective of pharmaceuticals. The first section focuses on the process of transforming a biologic macromolecule into a therapeutic agent, while the second section provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. Additional detail is also provided in the second section for each FDA approved, recombinantly derived biopharmaceutical for each category of macromolecule. The final section looks to the future and the new advances that will enhance our ability to develop new macromolecules into effective biopharmaceuticals. This last section discusses various drug delivery strategies while also describing gene and cell therapy strategies.
Biopharmaceuticals
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Author : Ming-Kung Yeh
language : en
Publisher: BoD – Books on Demand
Release Date : 2018-09-19
Biopharmaceuticals written by Ming-Kung Yeh and has been published by BoD – Books on Demand this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-19 with Medical categories.
Biopharmaceuticals are derived from biological sources, either live organisms or their active components; nowadays, they are mainly produced by biotechnologies. Biopharmaceuticals are extensively used in the treatment of various diseases such as cardiovascular, metabolic, neurological diseases, cancer, and others for which there are no available therapeutic methods. With the advance of science, biopharmaceuticals have revolutionized the treatment, prevention, and diagnosis of many patients with disabling and life-threatening diseases. Innovative biopharmaceuticals definitely improve the life quality of patients and enhance the effectiveness of the healthcare system. This book encompasses the discovery, production, application, and regulation of biopharmaceuticals to demonstrate their research achievement, prospects, and challenges. We expect the significance of biopharmaceuticals to be revealed and emphasized by this book.
Translational Medicine
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Author : Joy A. Cavagnaro
language : en
Publisher: CRC Press
Release Date : 2021-11-26
Translational Medicine written by Joy A. Cavagnaro and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-26 with Medical categories.
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.
Introduction To Biological And Small Molecule Drug Research And Development
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Author : C. Robin Ganellin
language : en
Publisher: Academic Press
Release Date : 2013-05-07
Introduction To Biological And Small Molecule Drug Research And Development written by C. Robin Ganellin and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-07 with Science categories.
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
Medicine And Biopharmaceutical
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Author : Masahide Takahashi
language : en
Publisher: World Scientific
Release Date : 2016-01-21
Medicine And Biopharmaceutical written by Masahide Takahashi and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-01-21 with Medical categories.
' This book provides an all-embracing review of each and every author''s study on the related topics and areas. For instance, some author''s study on Chinese Medicine, and some other researchers'' survey on biomedical engineering. Moreover, there are also papers that focus on information based bioinformatics, pharmacy and medicinal chemistry and biopharmaceutical technology. Contents:Medical ScienceBiomedical Engineering and BiotechnologyBiological PharmaceuticalFood Hygiene, Environment and Human Readership: Pharmaceutical researchers and health professionals. Key Features:This book contains a large range of topics, from medicine and medical science, bioinformatics to biomedical engineering and biological pharmaceutical. It is an invaluable source for other researchers, engineers, and academicians, as well as industrial professionalsIt welcomes authors from universities, institutions, labs, etc., which means that it provides different information according to different readers and different needsThis book will not only serve as a reference to the readers, but also an important tool for the authors to re-examine their researchers by comparing them to other similar ones shown in other papersKeywords:Medicine;Pharmacy;Traditional Chinese Medicine'
Biopharmaceutical Drug Design And Development
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Author : Susanna Wu-Pong
language : en
Publisher: Springer Science & Business Media
Release Date : 1999-04-01
Biopharmaceutical Drug Design And Development written by Susanna Wu-Pong and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-04-01 with Medical categories.
New discoveries in biology are occurring at an incredible rate, and with these discoveries arise nearly unimaginable opportunities in every area of human existence. Imagine the excitement surround ing the "penicillin project" and the subsequent rapid development of anti-infective agents that took place in the 1940s and 1950s. Fast for ward to the world today and our ability to treat life-threatening infec tions. This is but one small piece in the present kaleidoscope of new therapeutic agents. In fact, the world of science, biology, and medi cine is changing so quickly that it is difficult for scientists and medi cal practitioners to stay abreast of their fields and confidently anticipate that their education and training will sustain them over a three- to four-decade career without considerable continuing educa tion and training. For the pharmaceutical scientist responsible for the discovery and development of therapeutic agents based on advances in biotechnology, it is imperative to quickly come up to speed and stay at the forefront of developments, which is no easy task for those not specifically trained in this area. Biopharmaceutical Drug Design and Development, edited by Susanna Wu-Pong and Yongyut Rojanasakul, cuts a potentially wide swath in terms of its intended audience. It clearly is a primer for those not trained in the area, or for those who wish to be brought into the mainstream of drug discovery and development in the world of bio technology.
Innovation In The Biopharmaceutical Industry
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Author : Rifat A. Atun
language : en
Publisher: World Scientific
Release Date : 2007
Innovation In The Biopharmaceutical Industry written by Rifat A. Atun and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Medical categories.
Innovation is at the heart of all advances and has the capacity to solve problems facing humanity. Societies which have turned away from innovation and technological development have failed in their ability to support their populations. Understanding the nature of innovation in the life sciences and in particular healthcare, how it operates, what enables and hinders it is therefore of great importance to meeting the challenges ahead. This book, originally and concurrently published in the International Journal of Innovation Management, Vol. 11, No. 2, 2007, offers the latest research and insights concerning innovation in the biopharmaceutical industry.
Innovation In The Biopharmaceutical Industry
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Author :
language : en
Publisher:
Release Date :
Innovation In The Biopharmaceutical Industry written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Quality By Design For Biopharmaceutical Drug Product Development
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Author : Feroz Jameel
language : en
Publisher: Springer
Release Date : 2015-04-01
Quality By Design For Biopharmaceutical Drug Product Development written by Feroz Jameel and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-01 with Medical categories.
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
The Oxford Handbook Of The Economics Of The Biopharmaceutical Industry
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Author : Patricia M. Danzon
language : en
Publisher: Oxford University Press
Release Date : 2012-04-12
The Oxford Handbook Of The Economics Of The Biopharmaceutical Industry written by Patricia M. Danzon and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-12 with Business & Economics categories.
The biopharmaceutical industry has been a major driver of technological change in health care, producing unprecedented benefits for patients, cost challenges for payers, and profits for shareholders. As consumers and companies benefit from access to new drugs, policymakers around the globe seek mechanisms to control prices and expenditures commensurate with value. More recently the 1990s productivity boom of new products has turned into a productivity bust, with fewer and more modest innovations, and flat or declining revenues for innovative firms as generics replace their former blockbuster products. This timely volume examines the economics of the biopharmaceutical industry, with eighteen chapters by leading academic health economists. Part one examines the economics of biopharmaceutical innovation including determinants of the costs and returns to new drug development; how capital markets finance R&D and how costs of financing the biopharmaceutical industry compare to financing costs for other industries; the effects of safety and efficacy regulation by the Food and Drug Administration (FDA) and of price and reimbursement regulation on incentives for innovation; and the role of patents and regulatory exclusivities. Part two examines the market for biopharmaceuticals with chapters on prices and reimbursement in the US, the EU, and other industrialized countries, and in developing countries. It looks at the optimal design of insurance for drugs and the effects of cost sharing on spending and on health outcomes; how to measure the value of pharmaceuticals using pharmacoeconomics, including theory, practical challenges, and policy issues; how to measure pharmaceutical price growth over time and recent evidence; empirical evidence on the value of pharmaceuticals in terms of health outcomes; promotion of pharmaceuticals to physicians and consumers; the economics of vaccines; and a review of the evidence on effects of mergers, acquisitions and alliances. Each chapter summarizes the latest insights from theory and recent empirical evidence, and outlines important unanswered questions and areas for future research. Based on solid economics, it is nevertheless written in terms accessible to the general reader. The book is thus recommended reading for academic economists and non-economists, and for those in industry and policy who wish to understand the economics of this fascinating industry.