Biosimilars and Interchangeable Biologics

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Author :
Publisher : CRC Press
ISBN 13 : 149874348X
Total Pages : 599 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Biosimilars and Interchangeable Biologics by : Sarfaraz K. Niazi

Download or read book Biosimilars and Interchangeable Biologics written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-30 with total page 599 pages. Available in PDF, EPUB and Kindle. Book excerpt: What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

The Elements of Biologics

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Publisher :
ISBN 13 :
Total Pages : 164 pages
Book Rating : 4.:/5 (891 download)

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Book Synopsis The Elements of Biologics by : Eli Lilly and Company. Biologic Department

Download or read book The Elements of Biologics written by Eli Lilly and Company. Biologic Department and published by . This book was released on 1917 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Rare Diseases and Orphan Products

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Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

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.

Biologic Markers in Urinary Toxicology

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Author :
Publisher : National Academies Press
ISBN 13 : 0309052289
Total Pages : 322 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Biologic Markers in Urinary Toxicology by : National Research Council

Download or read book Biologic Markers in Urinary Toxicology written by National Research Council and published by National Academies Press. This book was released on 1995-08-28 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: Diseases of the kidney, bladder, and prostate exact an enormous human and economic toll on the population of the United States. This book examines prevention of these diseases through the development of reliable markers of susceptibility, exposure, and effect and the promise that new technologies in molecular biology and sophisticated understanding of metabolic pathways, along with classical approaches to the study of nephrotoxicants and carcinogens, can be developed and prevention of the diseases achieved. The specific recommendations included in this book complement those made in the previous three volumes on biomarkers, Biologic Markers in Reproductive Toxicology (1989), Biologic Markers in Pulmonary Toxicology (1989), and Biologic Markers in Immunotoxicology (1991).

Biologics, A History of Agents Made From Living Organisms in the Twentieth Century

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Author :
Publisher : Routledge
ISBN 13 : 1317319095
Total Pages : 279 pages
Book Rating : 4.3/5 (173 download)

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Book Synopsis Biologics, A History of Agents Made From Living Organisms in the Twentieth Century by : Alexander von Schwerin

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.

Safe and Effective Medicines for Children

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Publisher : National Academies Press
ISBN 13 : 0309225493
Total Pages : 432 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

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.

Biodefense in the Age of Synthetic Biology

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Author :
Publisher : National Academies Press
ISBN 13 : 0309465184
Total Pages : 189 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Biodefense in the Age of Synthetic Biology by : National Academies of Sciences, Engineering, and Medicine

Download or read book Biodefense in the Age of Synthetic Biology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-01-05 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.

Biologics, Biosimilars, and Biobetters

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1119564654
Total Pages : 328 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Biologics, Biosimilars, and Biobetters by : Iqbal Ramzan

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

Essentials of Glycobiology

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Publisher : CSHL Press
ISBN 13 : 9780879696818
Total Pages : 694 pages
Book Rating : 4.6/5 (968 download)

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Book Synopsis Essentials of Glycobiology by : Ajit Varki

Download or read book Essentials of Glycobiology written by Ajit Varki and published by CSHL Press. This book was released on 1999 with total page 694 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sugar chains (glycans) are often attached to proteins and lipids and have multiple roles in the organization and function of all organisms. "Essentials of Glycobiology" describes their biogenesis and function and offers a useful gateway to the understanding of glycans.

Principles of Translational Science in Medicine

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Publisher : Academic Press
ISBN 13 : 0128007214
Total Pages : 365 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Principles of Translational Science in Medicine by : Martin Wehling

Download or read book Principles of Translational Science in Medicine written by Martin Wehling and published by Academic Press. This book was released on 2015-04-02 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine. - Provides an in-depth description of novel tools for the assessment of translatability of trials to balance risk and improve projects at any given stage of product development - New chapters deal with translational issues in the fastest growing population (the elderly), case studies, translatability assessment tools, and advances in nanotherapies - Details IPR issues of translation, especially for public-private-partnerships - Contains contributions from world leaders in translational medicine, including the former NIH director and authorities from various European regulatory institutions

Drug Bulletin

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Publisher :
ISBN 13 :
Total Pages : 1026 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Drug Bulletin by :

Download or read book Drug Bulletin written by and published by . This book was released on 1928 with total page 1026 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Science and Security in a Post 9/11 World

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Author :
Publisher : National Academies Press
ISBN 13 : 0309111919
Total Pages : 136 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Science and Security in a Post 9/11 World by : National Research Council

Download or read book Science and Security in a Post 9/11 World written by National Research Council and published by National Academies Press. This book was released on 2007-11-10 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on a series of regional meetings on university campuses with officials from the national security community and academic research institutions, this report identifies specific actions that should be taken to maintain a thriving scientific research environment in an era of heightened security concerns. Actions include maintaining the open exchange of scientific information, fostering a productive environment for international scholars in the U.S., reexamining federal definitions of sensitive but unclassified research, and reviewing policies on deemed export controls. The federal government should establish a standing entity, preferably a Science and Security Commission, that would review policies regarding the exchange of information and the participation of foreign-born scientists and students in research.

Basic Principles of Drug Discovery and Development

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Publisher : Academic Press
ISBN 13 : 0128172150
Total Pages : 738 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Basic Principles of Drug Discovery and Development by : Benjamin E. Blass

Download or read book Basic Principles of Drug Discovery and Development written by Benjamin E. Blass and published by Academic Press. This book was released on 2021-03-30 with total page 738 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator's fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist's early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. - Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property - Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape - Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery - Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry

Essential Elements for a GMP Analytical Chemistry Department

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 1461476429
Total Pages : 203 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Essential Elements for a GMP Analytical Chemistry Department by : Thomas Catalano

Download or read book Essential Elements for a GMP Analytical Chemistry Department written by Thomas Catalano and published by Springer Science & Business Media. This book was released on 2013-06-20 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential elements such as , SOP’s, regulatory guidance’s/guidelines, project teams, technical and department processes, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including start-up, virtual, and generic pharmaceutical companies. ​

Preventing Medication Errors

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Publisher : National Academies Press
ISBN 13 : 0309133734
Total Pages : 480 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Preventing Medication Errors by : Institute of Medicine

Download or read book Preventing Medication Errors written by Institute of Medicine and published by National Academies Press. This book was released on 2006-12-11 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.

Biosimilars and Interchangeable Biologics

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Author :
Publisher : CRC Press
ISBN 13 : 1351231308
Total Pages : 638 pages
Book Rating : 4.3/5 (512 download)

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Book Synopsis Biosimilars and Interchangeable Biologics by : Sarfaraz K. Niazi

Download or read book Biosimilars and Interchangeable Biologics written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-30 with total page 638 pages. Available in PDF, EPUB and Kindle. Book excerpt: What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Research at the Intersection of the Physical and Life Sciences

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Author :
Publisher : National Academies Press
ISBN 13 : 0309147514
Total Pages : 122 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Research at the Intersection of the Physical and Life Sciences by : National Research Council

Download or read book Research at the Intersection of the Physical and Life Sciences written by National Research Council and published by National Academies Press. This book was released on 2010-03-25 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traditionally, the natural sciences have been divided into two branches: the biological sciences and the physical sciences. Today, an increasing number of scientists are addressing problems lying at the intersection of the two. These problems are most often biological in nature, but examining them through the lens of the physical sciences can yield exciting results and opportunities. For example, one area producing effective cross-discipline research opportunities centers on the dynamics of systems. Equilibrium, multistability, and stochastic behavior-concepts familiar to physicists and chemists-are now being used to tackle issues associated with living systems such as adaptation, feedback, and emergent behavior. Research at the Intersection of the Physical and Life Sciences discusses how some of the most important scientific and societal challenges can be addressed, at least in part, by collaborative research that lies at the intersection of traditional disciplines, including biology, chemistry, and physics. This book describes how some of the mysteries of the biological world are being addressed using tools and techniques developed in the physical sciences, and identifies five areas of potentially transformative research. Work in these areas would have significant impact in both research and society at large by expanding our understanding of the physical world and by revealing new opportunities for advancing public health, technology, and stewardship of the environment. This book recommends several ways to accelerate such cross-discipline research. Many of these recommendations are directed toward those administering the faculties and resources of our great research institutions-and the stewards of our research funders, making this book an excellent resource for academic and research institutions, scientists, universities, and federal and private funding agencies.