December 2, 2020

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Social Aspects of Drug Discovery, Development and Commercialization

Social Aspects of Drug Discovery, Development and Commercialization
Author : Odilia Osakwe,Syed A.A. Rizvi
Publisher : Academic Press
Release Date : 2016-02-18
Category : Medical
Total pages :324
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Social Aspects of Drug Discovery, Development and Commercialization provides an insightful analysis of the drug discovery and development landscape as it relates to society. This book examines the scientific, legal, philosophical, economic, political, ethical and cultural factors that contribute to drug development. The pharmaceutical industry is under scrutiny to develop safer and more effective drugs in a quicker and more affordable manner. Recent criticism and debates have emphasized varying opinions on the issues concerning the drug discovery and development process. This book provides thoughtful and valuable discussions and analysis of the social challenges and potential opportunities through all stages of the pharmaceutical process, from inception through marketing. With a unique focus on the social factors that increasingly play a role in how drug development is planned, structured, and executed throughout the drug product lifecycle, this is an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society. Organized in a sequence of interrelated theories and principles that provide the foundation for increased understanding of the relevant social aspects Includes analysis of important new advances, key scientific and strategic issues, and overviews of recent progress in drug development Provides a global perspective with examples from developed areas, such as the US, Japan, Canada and Europe, as well as faster-growing and emerging economies including Brazil, Russia, India, and China Serves as an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society

Advertising Theory

Advertising Theory
Author : Shelly Rodgers,Esther Thorson
Publisher : Routledge
Release Date : 2019-04-15
Category : Business & Economics
Total pages :548
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Advertising Theory provides detailed and current explorations of key theories in the advertising discipline. The volume gives a working knowledge of the primary theoretical approaches of advertising, offering a comprehensive synthesis of the vast literature in the area. Editors Shelly Rodgers and Esther Thorson have developed this volume as a forum in which to compare, contrast, and evaluate advertising theories in a comprehensive and structured presentation. With new chapters on forms of advertising, theories, and concepts, and an emphasis on the role of new technology, this new edition is uniquely positioned to provide detailed overviews of advertising theory. Utilizing McGuire’s persuasion matrix as the structural model for each chapter, the text offers a wider lens through which to view the phenomenon of advertising as it operates within various environments. Within each area of advertising theory—and across advertising contexts—both traditional and non-traditional approaches are addressed, including electronic word-of-mouth advertising, user-generated advertising, and social media advertising contexts. This new edition includes a balance of theory and practice that will help provide a working knowledge of the primary theoretical approaches and will help readers synthesize the vast literature on advertising with the in-depth understanding of practical case studies and examples within every chapter. It also looks at mobile advertising in a broader context beyond the classroom and explores new areas such as native advertising, political advertising, mobile advertising, and digital video gaming.

Managing the Drug Discovery Process

Managing the Drug Discovery Process
Author : Walter Moos,Susan Miller,Stephen Munk,Barbara Munk
Publisher : Woodhead Publishing
Release Date : 2016-11-08
Category : Medical
Total pages :536
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Managing the Drug Discovery Process: How to Make It More Efficient and Cost-Effective thoroughly examines the current state of pharmaceutical research and development by providing chemistry-based perspectives on biomedical research, drug hunting and innovation. The book also considers the interplay of stakeholders, consumers, and the drug firm with attendant factors, including those that are technical, legal, economic, demographic, political, social, ecological, and infrastructural. Since drug research can be a high-risk, high-payoff industry, it is important to researchers to effectively and strategically manage the drug discovery process. This book takes a closer look at increasing pre-approval costs for new drugs and examines not only why these increases occur, but also how they can be overcome to ensure a robust pharmacoeconomic future. Written in an engaging manner and including memorable insights, this book is aimed at redirecting the drug discovery process to make it more efficient and cost-effective in order to achieve the goal of saving countless more lives through science. A valuable and compelling resource, this is a must-read for all students and researchers in academia and the pharmaceutical industry. Considers drug discovery in multiple R&D venues, including big pharma, large biotech, start-up ventures, academia, and nonprofit research institutes Analyzes the organization of pharmaceutical R&D, taking into account human resources considerations like recruitment and configuration, management of discovery and development processes, and the coordination of internal research within, and beyond, the organization, including outsourced work Presents a consistent, well-connected, and logical dialogue that readers will find both comprehensive and approachable

Innovation and Marketing in the Pharmaceutical Industry

Innovation and Marketing in the Pharmaceutical Industry
Author : Min Ding,Jehoshua Eliashberg,Stefan Stremersch
Publisher : Springer Science & Business Media
Release Date : 2013-10-31
Category : Medical
Total pages :768
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The pharmaceutical industry is one of today’s most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success—or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: · An extensive literature review, including coverage of research from fields other than marketing · an overview of how practitioners have addressed the topic · introduction of relevant analytical tools, such as statistics and ethnographic studies · suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.

Biomarkers in Drug Discovery and Development

Biomarkers in Drug Discovery and Development
Author : Ramin Rahbari,Jonathan Van Niewaal,Michael R. Bleavins
Publisher : John Wiley & Sons
Release Date : 2020-02-28
Category : Medical
Total pages :608
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This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development. • Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine • Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory • Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring • Includes case studies of biomarkers that have helped and hindered decision making • Reviews of the first edition: “If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn't be, then this book is for you." (ISSX) and “...provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation.” (ChemMedChem)

Achieving Proof of Concept in Drug Discovery and Development

Achieving Proof of Concept in Drug Discovery and Development
Author : Helen Yu
Publisher : Edward Elgar Publishing
Release Date : 2016-11-25
Category :
Total pages :304
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One of the major shortcomings of the current drug discovery and development process is the inability to bridge the gap between early stage discoveries and pre-clinical research in order to advance innovations beyond the discovery phase. This book examines a drug discovery and development model, where the respective expertise of academia and industry are brought together to take promising discoveries through to proof of concept, providing a means to de-risk the drug discovery and development process.

Federal R&d, Drug Discovery, and Pricing

Federal R&d, Drug Discovery, and Pricing
Author : Wendy H. Schacht
Publisher : DIANE Publishing
Release Date : 2012-10-10
Category :
Total pages :32
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Public interest in approaches that might provide prescription drugs at lower cost, particularly for the elderly, has rekindled discussion over the role the federal government plays in facilitating the creation of new pharmaceuticals for the marketplace. The government traditionally funds R&D to meet the mission requirements of the federal departments and agencies. It also supports work in areas where there is an identified need for research, primarily basic research, not being performed in the private sector. Congressional initiatives have expanded to include the promotion of technological innovation to meet other national needs, particularly the economic growth that flows from the use of new and improved goods and services. Various laws facilitate commercialization of federally funded R&D through technology transfer, cooperative R&D, and intellectual property rights. Contents of this report: Overview; Government Support for R&D; Industrial R&D; Patents; Legislative Initiatives; NIH-University-Industry Collaboration; Pricing Decisions and Recoupment; Research Tools; Government Rights: Royalty Free Licenses and Reporting Requirements; Conclusion. Figures. This is a print on demand report.

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
Author : Divya Vohora,Gursharan Singh
Publisher : Academic Press
Release Date : 2017-11-14
Category : Medical
Total pages :526
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Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Intellectual Property, Entrepreneurship and Social Justice

Intellectual Property, Entrepreneurship and Social Justice
Author : Lateef Mtima
Publisher : Edward Elgar Publishing
Release Date : 2015-02-27
Category : Law
Total pages :320
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In the Information Age, historically marginalized groups and developing nations continue to strive for socio-economic empowerment within the global community. Their ultimate success largely depends upon their ability to develop, protect, and exploit th

Pharmaceutical Nanotechnology

Pharmaceutical Nanotechnology
Author : Jean Cornier
Publisher : John Wiley & Sons
Release Date : 2017-02-06
Category : Medical
Total pages :775
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With its focus on concrete methods and recent advances in applying nanotechnology to develop new drug therapies and medical diagnostics, this book provides an overall picture of the field, from the fundamentals of nanopharmacy with the characterisation and manufacturing methods to the role of nanoparticles and substances. Actual examples of utilization include drug development issues, translation to the clinic, market prospects, and industrial commercialization aspects. The applications described are taken from cancer treatment as well as other major therapeutic areas, such as infectious diseases and dermatology. An in-depth discussion on safety, regulatory, and societal aspects rounds off the book. Written by a top team of editors and authors composed of the leading experts in Europe and the USA who have pioneered the field of nanopharmacy!

Monte Carlo Simulation for the Pharmaceutical Industry

Monte Carlo Simulation for the Pharmaceutical Industry
Author : Mark Chang
Publisher : CRC Press
Release Date : 2010-09-29
Category : Mathematics
Total pages :564
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Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods needed to carry out computer simulations efficiently, covers both descriptive and pseudocode algorithms that provide the basis for implementation of the simulation methods, and illustrates real-world problems through case studies. The text first emphasizes the importance of analogy and simulation using examples from a variety of areas, before introducing general sampling methods and the different stages of drug development. It then focuses on simulation approaches based on game theory and the Markov decision process, simulations in classical and adaptive trials, and various challenges in clinical trial management and execution. The author goes on to cover prescription drug marketing strategies and brand planning, molecular design and simulation, computational systems biology and biological pathway simulation with Petri nets, and physiologically based pharmacokinetic modeling and pharmacodynamic models. The final chapter explores Monte Carlo computing techniques for statistical inference. This book offers a systematic treatment of computer simulation in drug development. It not only deals with the principles and methods of Monte Carlo simulation, but also the applications in drug development, such as statistical trial monitoring, prescription drug marketing, and molecular docking.

Benefit-Risk Assessment in Pharmaceutical Research and Development

Benefit-Risk Assessment in Pharmaceutical Research and Development
Author : Andreas Sashegyi,James Felli,Rebecca Noel
Publisher : CRC Press
Release Date : 2013-11-27
Category : Mathematics
Total pages :220
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Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment. The book first presents interpretations of benefit and risk in the context of a molecule moving from preclinical evaluation into its early testing in humans. It next considers benefit and risk characterization and assessment during a molecule’s journey from its clinical evaluation in humans through its submission to regulators for marketing approval. Throughout these sections, the book offers insight into the role of benefit-risk assessment in heightening understanding among key stakeholders by shaping questions and guiding discussions among scientists, physicians, developers, and regulatory agencies. The book also focuses on a molecule’s entry into the marketplace as a drug available for consumption by people. It explores the role of benefit-risk assessment as the relevance of carefully collected clinical efficacy and safety metrics fades in the wake of real-world use and evidence of effectiveness and safety. Bringing together the expertise of 15 contributors from academia and the industry, this book offers an easy-to-read guide to the various facets of benefit-risk assessment in the major stages of pharmaceutical R&D. Suitable for those in both technical and managerial roles, it enables readers to communicate more effectively across their development chain as well as rationally and thoughtfully embed benefit-risk assessment into their R&D processes.

Peptide Drug Discovery and Development

Peptide Drug Discovery and Development
Author : Miguel Castanho,Nuno Santos
Publisher : John Wiley & Sons
Release Date : 2011-10-24
Category : Medical
Total pages :390
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Filling a real knowledge gap, this handbook and ready reference is both modern and forward-looking in its emphasis on the "bench to bedside" translational approach to drug development. Clearly structured into three major parts, the book stakes out the boundaries of peptide drug development in the preclinical as well as clinical stages. The first part provides a general background and focuses on the characteristic strengths and weaknesses of peptide drugs. The second section contains five cases studies of peptides from diverse therapeutic fields, and the lessons to be learned from them, while the final part looks at new targets and opportunities, discussing several drug targets and diseases for which peptide drugs are currently being developed.

Biotechnology Research Abstracts

Biotechnology Research Abstracts
Author : Anonim
Publisher : Unknown
Release Date : 1988
Category : Biotechnology
Total pages :129
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Monthly. Classified listing of references to worldwide articles dealing with all aspects of biotechnology. Also includes books and conferences. Each entry gives bibliographic information, institutional address of author(s), and abstract. Author and subject index.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Release Date : 2014-02-06
Category : Medical
Total pages :118
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Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.