Author: Renee J. G. Arnold
Publisher: CRC Press
ISBN: 9781420084405
Size: 21.11 MB
Format: PDF, Kindle
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The pharmaceutical industry is almost boundless in its ability to supply new drug therapies, but how does one decide which are the best medicines to use within restricted budgets? With particular emphasis on modeling, methodologies, data sources, and application to real-world dilemmas, Pharmacoeconomics: From Theory to Practice provides an introduction to the major concepts and principles of pharmacoeconomics and cost-effectiveness analysis (CEA). As a running theme, the book explores the collaboration among members of the pharmaceutical industry, academia, and government in the development of the human papillomavirus vaccine to demonstrate the full range of ethical and moral issues, as well as overall public health and commercial concerns that are often involved in decisions entailing CEA. Readers will learn about the international use of pharmacoeconomics in drug regulation, drug approval, and pricing, and the book provides examples of pharmacoeconomic models used to support these purposes in government, the pharmaceutical industry, and healthcare settings. In this era of finite budgets, healthcare rationing, medication shortages, and the global aging and burgeoning of populations, numerous stakeholders in the healthcare arena must understand the basic principles of pharmacoeconomics and how these may be correctly applied to facilitate drug development, drug approval, rationing, patient segmentation, disease management, and pricing model development. Focusing on how to save money, not by restricting access to necessary services, but by using available resources more efficiently and rationally, this volume arms decision makers with the tools they need to make wise choices in an area where the stakes are so high. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.

Phage Display In Biotechnology And Drug Discovery Second Edition

Author: Sachdev S. Sidhu
Publisher: CRC Press
ISBN: 1439836507
Size: 77.82 MB
Format: PDF, ePub, Docs
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Phage Display in Biotechnology and Drug Discovery, Second Edition provides a comprehensive view of the impact and promise of phage display in drug discovery and biotechnology. Building on the success of its previous edition, the book discusses current theories, principles, and methods in the field and demonstrates applications for peptide phage display, protein phage display, and the development of novel antibodies. The book provides readers with an overview of the amazing breadth of the impact that phage display technology has had on the study of proteins in general as well as the development of proteins. It will be a valuable resource for those interested in using phage display and recombinant antibodies in basic research and drug discovery.


Author: Lorenzo Pradelli
Publisher: SEEd
ISBN: 8897419380
Size: 14.50 MB
Format: PDF, ePub, Docs
View: 459
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Economic issues related to the health sector have been gaining much attention in recent years, and the challenge of providing quality and comprehensive health care to a growing population has become increasingly complex. This book’s aim is to introduce readers to basic principles of economics and to a set of analytical tools of economic evaluations and their application in the health sector. The most important evaluation techniques are explained by examples: cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis and cost-benefit analysis.

Strategies In Pharmacoeconomics And Outcomes Research

Author: Albert I Wertheimer
Publisher: CRC Press
ISBN: 9780789015853
Size: 38.75 MB
Format: PDF
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Get a healthy perspective on pharmaceutical economics! Strategies in Pharmacoeconomics and Outcomes Research presents a comprehensive introduction to the economic aspects of the health sector, focusing on strategies for the development and marketing of healthcare products. A much-needed addition to this relatively new field, the book narrows health economics into the sub-discipline of pharmacoeconomics, bridging the gap between different interest groups in the pharmaceutical industry-research and development at one end, sales and marketing at the other. Using basic terminology and practical examples with descriptive tables and figures, it analyzes the implications of projecting costs of pharmaceutical products as a method of determining the viability of their development. Written from an international perspective, Strategies in Pharmacoeconomics and Outcomes Research examines the costs of drug therapy on health care systems and society through global marketing and modeling strategies, including clinical research and trial examples. Through the interlinked concepts of clinical research, outcomes research and pharmacoeconomics, the book evaluates the effectiveness of health technologies under “real world” circumstances or “normal” medical practice to achieve the optimum benefit from the resources available. The research process follows the economics of a drug?s efficacy (how it works under ideal circumstances) to its effectiveness (how it does in “real” life) to its efficiency (how cost-effective it is) in determining the baseline effects of a disease on economic and humanistic parameters. Strategies in Pharmacoeconomics and Outcomes Research also examines: resources and cost benefits (direct, indirect, intangible, and quality of life) health economical models (decision-tree analysis, Markov-model) reimbursement differences between countries due to the rate of currency exchange drug monitoring and regulation . . . and includes an extensive glossary! At a time when health economics has become increasingly important, Strategies in Pharmacoeconomics and Outcomes Research is an essential tool for the pharmaceutical, diagnostic, and medical device industries to ensure the most efficient use of limited resources. The book?s practical tone and common-sense methods provide a realistic approach that will benefit pharmaceutical and medical professionals, product managers, business development managers, drug regulatory affairs officials, and clinical study coordinators in making strategic and operational decisions about pharmaceutical development, production, or consumption.

Drug Repositioning

Author: Joel Dudley
Publisher: CRC Press
ISBN: 131535621X
Size: 13.79 MB
Format: PDF, ePub, Mobi
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Nervous system diseases represent a major health concern worldwide. Although important financial and professional investment, their etiology and pathophysiology still remain mostly elusive. Moreover, the clinical need of disease-modifying therapies is still unmet. In the last decades, traditional R&D has failed in identifying new effective therapies in many medical areas and drug repositioning has recently emerged as a promising alternative strategy to de novo drug discovery to improve and accelerate therapeutic development. For the first time, Drug Repositioning: Approaches and Applications for Neurotherapeutics reviews history and advances in drug repositioning, with a special focus on therapeutics for nervous system diseases. International experts from Academia, Industry and Non-profit organisations will provide different views on drug repositioning advantages, challenges and specific applications, which will be covered for nervous system diseases including Alzheimer's, Parkinson's, Huntington's diseases, Amyotrophic Lateral Sclerosis, Spinal Muscular Atrophy, ischemic stroke, and psychiatric disorders. This book provides a balanced overview and synthesis of drug repositioning concept, methods and applications for neurotherapeutics. It represents a valuable resource for students, scientists and clinicians working in academic settings, industry and government agencies within the fields of neuroscience, pharmacology, neurology, pharmaceutical sciences, drug discovery and development.

The Clinical Practice Of Drug Information

Author: Michael Gabay
Publisher: Jones & Bartlett Publishers
ISBN: 128402623X
Size: 38.89 MB
Format: PDF, ePub, Mobi
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The Clinical Practice of Drug Information provides information on various resources, approaches to answering drug information requests, evaluating the biomedical literature, study design, statistical concepts, bioinformatics, medication safety, development of medication use policies, medication safety, formulary management, evidence-based medicine, and pharmacy informatics. This resources will educate students and pharmacists on traditional drug information topics while providing an extensive background on more recent practice areas. This is a user-friendly text with multiple examples that can be used in education and training, as well as clinical practice. Each chapter includes learning objectives, key terms, examples and cases, and review questions. Instructor Resources: Instructor's Manual, Slides in PowerPoint format, Test Bank Each new print copy includes Navigate 2 Advantage Access that unlocks a comprehensive and interactive eBook, student practice activities and assessments, and for instructors: a full suite of teaching tools, and learning analytics reporting.

The Oxford Handbook Of The Economics Of The Biopharmaceutical Industry

Author: Patricia M. Danzon
Publisher: Oxford University Press
ISBN: 0199909261
Size: 36.17 MB
Format: PDF, ePub
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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.

Understanding Health Outcomes And Pharmacoeconomics

Author: George E. MacKinnon III
Publisher: Jones & Bartlett Publishers
ISBN: 1449677401
Size: 80.47 MB
Format: PDF, Docs
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Understanding Health Outcomes and Pharmacoeconomics presents an overview of the tools used to assess patient-related health status including associated health outcomes and the analyses that are used to determine cost-effectiveness in evaluating pharmacotherapeutic interventions to improve health. Including data and examples from several different countries, this comprehensive text will help students understand the basis for decisions made at the local and governmental level that impact the use of pharmaceuticals and provide a strong foundation for understanding the principles used in cost-effective decision making. With commentaries, cases studies, and highlighting international differences, this text concludes with a discussion of the need for a universal system for documenting medication use. Understanding Health Outcomes and Pharmacoeconomics provides definitions of comparative effectiveness research (CER) and comparisons of pharmacoeconomic models (including cost-effectivess, cost-benefit, and cost utility analyses). This inclusive text provides describes how CER is linked to various pharmacoeconomic models by providing examples from clinical trials with comparative pharmacotherapy and cost parameters. From the Introduction: “The need for interprofessional education was made apparent in the 2003 Health Professions Education: A Bridge to Quality report. All healthcare professionals must be educated to deliver patient-centered care as members of an interprofessional team, emphasizing evidence-based practice, quality improvement approaches, and informatics. An enhanced understanding of pharmacoeconomic principles is a step in the right direction for healthcare practitioners as we do our best to ensure optimal medication therapy outcomes for patients and society at-large.” — George E. MacKinnon III, PhD, RPh, FASHP

Equitable Access To High Cost Pharmaceuticals

Author: Zaheer-Ud-Din Babar
Publisher: Academic Press
ISBN: 0128119624
Size: 35.83 MB
Format: PDF, ePub
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Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines. Evaluates impact and efficacy of current access policies and pricing regulation of high-cost drugs Incorporates existing guidelines and recommendations by international organizations Compares and contrasts how different countries fund and police high-cost drug access Explores novel and emergent policies, including managed entry agreement, analysis of real world data and differential pricing Reviews novel pharmaceuticals of current research interest

Multiregional Clinical Trials For Simultaneous Global New Drug Development

Author: Joshua Chen
Publisher: CRC Press
ISBN: 1498701485
Size: 43.93 MB
Format: PDF, Kindle
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In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, industry, and health organizations address various aspects of the important problems in global clinical development and MRCTs. The book first provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical development using MRCTs. It then focuses on the design, monitoring, and analysis/interpretation of MRCTs. The book concludes with an examination of the latest research topics from MRCT perspectives, such as special considerations by local health authorities, health economic evaluations, benefit-risk assessment, and medical devices. Explaining how to design, conduct, and interpret MRCTs, this book will help biostatisticians working in the late-stage clinical development of medical products. It will also be useful for statisticians and clinicians in the biopharmaceutical industry, regulatory agencies, and medical research institutes.