Download or read book A Practical Approach to Pharmaceutical Policy written by Andreas Seiter and published by World Bank Publications. This book was released on 2010-06-17 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.
Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Download or read book Research Methods for Pharmaceutical Practice and Policy written by Rajender R. Aparasu and published by Pharmaceutical Press. This book was released on 2011 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text provides the theory and practice for conducting pharmaceutical policy research. It covers all aspects of scientific research from conceptualising to statistical analysis. It also provides scientific basis and a good understanding of the principles and practice of conducting pharmaceutical policy research.
Download or read book A Practical Guide to Drug Development in Academia written by Daria Mochly-Rosen and published by Springer Science & Business Media. This book was released on 2014-07-08 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. "I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."
Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Download or read book Pharmacovigilance A Practical Approach written by Thao Doan and published by Elsevier Health Sciences. This book was released on 2018-07-31 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
Download or read book Pharmacotherapeutics for Advanced Practice written by Virginia Poole Arcangelo and published by LWW. This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publisher's Note: Products purchased from 3rd Party sellers are not guaranteed by the Publisher for quality, authenticity, or access to any online entitlements included with the product. Be ready to prescribe and administer drugs safely and effectively--and grasp all the vitals of pharmacology--with the fully updated Pharmacotherapeutics for Advanced Practice, 4th edition. Written by pharmacology nursing experts, this easy-to-read text offers proven frameworks for treating more than 50 common diseases and disorders. Learn how to identify disorders, review possible therapies, then prescribe and monitor drug treatment, accurately. Based on current evidence and real-life patient scenarios, this is the perfect pharmacology learning guide and on-the-spot clinical resource. Absorb the key principles and practical methods for accurate prescribing and monitoring, with . . . NEW chapter on Parkinson's disease, osteoarthritis, and rheumatoid arthritis NEWand updated therapies, and updated and additional case studies, with sample questions NEW content on the impacts of the Affordable Care Act Updated chapters on complementary and alternative medicine (CAM) and pharmacogenomics Updated evidence-basedalgorithms and drugtables - Listing uses, mechanisms, adverse effects, drug interactions, contraindications, and monitoring parameters, organized by drug class; quick access to generic and trade names and dosages Quick-scan format organizes information by body system Chapter features include: Brief overview - Pathophysiology of each disorder, and relevant classes of drugs Monitoring Patient Response section - What to monitor, and when Patient Education section - Includes information on CAM for each disorder Drug Overview tables - Usual dose, contraindications and side effects, and special considerations Algorithms - Visual cues on how to approach treatment Updated Recommended Order of Treatment tables - First-, second- and third-line drug therapies for each disorder Answers to Case Study Questions for each disorder - Strengthens critical thinking skills Selecting the Most Appropriate Agentsection - The thought process for choosing an initial drug therapy Principles of Therapeuticsunit - Avoiding medication errors; pharmacokinetics and pharmacodynamics; impact of drug interactions and adverse events; principles of pharmacotherapy for pediatrics, pregnancy/lactation, and geriatrics Disorders units - Pharmacotherapy for disorders in various body systems Pharmacotherapy in Health Promotion unit - Smoking cessation, immunizations, weight management Women's Health unit - Including contraception, menopause, and osteoporosis Integrative Approach to Patient Care unit - Issues to consider when presented with more than one diagnosis Standard pharmacotherapeutics text for nurse practitioners, students, and physician assistants Ancillaries - Case Study answers, multiple choice questions and answers for every chapter, PowerPoints, Acronyms List
Download or read book Drug Policy and the Public Good written by Thomas F. Babor and published by Oxford University Press. This book was released on 2010 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Policy and the Public Good is a book by an international group of addiction scientists, to improve the links between addiction science and drug policy. It presents the accumulated scientific knowledge on drug use research that has a direct relevance to the development of drug policy at local, national and international levels.
Download or read book The Right Price written by Peter J. Neumann and published by Oxford University Press. This book was released on 2021 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: The prescription drug market -- Proposed solutions for rising drug prices -- Measuring the value of prescription drugs -- Measuring drug value : whose job is it anyway? -- Institute for Clinical and Economic Review (ICER) -- Other US value assessment frameworks -- Do drugs for special populations warrant higher prices? -- Improving value measurement -- Aligning prices with value -- The path forward.
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Download or read book Getting Health Reform Right written by Marc Roberts and published by Oxford University Press. This book was released on 2008-04-23 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a multi-disciplinary framework for developing and analyzing health sector reforms, based on the authors' extensive international experience. It offers practical guidance - useful to policymakers, consultants, academics, and students alike - and stresses the need to take account of each country's economic, administrative, and political circumstances. The authors explain how to design effective government interventions in five areas - financing, payment, organization, regulation, and behavior - to improve the performance and equity of health systems around the world.
Download or read book Budget Impact Analysis of Health Care Interventions written by Josephine Mauskopf and published by Springer. This book was released on 2017-08-04 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first of its kind for budget-impact analysis, this comprehensive guide provides clear and concise instructions for evaluating the impact that new pharmaceuticals will have on the budget for a specific jurisdiction. The book demonstrates how to create a budget-impact analysis using a simple six-step process that is consistent with current guidelines for these analyses. Examples and exercises for each chapter afford an opportunity to practice the six-step process in practical applications. The book progresses from a framework for budget impact analyses to an in-depth review of components and how to develop and present these in software applications and reports. Critical considerations such as uncertainty analysis and validation, and considerations for alternate interventions, such as vaccines and diagnostics, are also covered. This book is a “must have” for the builder and budget holder, with builders benefiting from instructions to identify and estimate all necessary variables and budget holders receiving a guide to what should be included in the analyses they assess.
Download or read book Cost Effectiveness Analysis in Health written by Peter Muennig and published by John Wiley & Sons. This book was released on 2016-02-03 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field's bestselling reference, updated with the latest tools, data, techniques, and the latest recommendations from the Second Panel on Cost-Effectiveness in Health and Medicine Cost-Effectiveness Analysis in Health is a practical introduction to the tools, methods, and procedures used worldwide to perform cost-effective research. Covering every aspect of a complete cost-effectiveness analysis, this book shows you how to find which data you need, where to find it, how to analyze it, and how to prepare a high-quality report for publication. Designed for the classroom or the individual learner, the material is presented in simple and accessible language for those who lack a biostatistics or epidemiology background, and each chapter includes real-world examples and "tips and tricks" that highlight key information. Exercises throughout allow you to test your understanding with practical application, and the companion website features downloadable data sets for students, as well as lecture slides and a test bank for instructors. This new third edition contains new discussion on meta-analysis and advanced modeling techniques, a long worked example using visual modeling software TreeAge Pro, and updated recommendations from the U.S. Public Health Service's Panel on Cost-Effectiveness in Health and Medicine. This is the second printing of the 3rd Edition, which has been corrected and revised for 2018 to reflect the latest standards and methods. Cost-effectiveness analysis is used to evaluate medical interventions worldwide, in both developed and developing countries. This book provides process-specific instruction in a concise, structured format to give you a robust working knowledge of common methods and techniques. Develop a thoroughly fleshed-out research project Work accurately with costs, probabilities, and models Calculate life expectancy and quality-adjusted life years Prepare your study and your data for publication Comprehensive analysis skills are essential for students seeking careers in public health, medicine, biomedical research, health economics, health policy, and more. Cost-Effectiveness Analysis in Health walks you through the process from a real-world perspective to help you build a skillset that's immediately applicable in the field.
Download or read book Conflict of Interest in Medical Research Education and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-09-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Download or read book Practical Process Research and Development written by Neal G. Anderson and published by Academic Press. This book was released on 2012-05-23 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed to provide a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries, this book describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. It describes hands-on, step-by-step, approaches to solving process development problems, including route, reagent, and solvent selection; optimising catalytic reactions; chiral syntheses; and "green chemistry." Second Edition highlights:• Reflects the current thinking in chemical process R&D for small molecules• Retains similar structure and orientation to the first edition. • Contains approx. 85% new material• Primarily new examples (work-up and prospective considerations for pilot plant and manufacturing scale-up)• Some new/expanded topics (e.g. green chemistry, genotoxins, enzymatic processes)• Replaces the first edition, although the first edition contains useful older examples that readers may refer to Provides insights into generating rugged, practical, cost-effective processes for the chemical preparation of "small molecules" Breaks down process optimization into route, reagent and solvent selection, development of reaction conditions, workup, crystallizations and more Presents guidelines for implementing and troubleshooting processes
