A Practical Approach to Pharmaceutical Policy

A Practical Approach to Pharmaceutical Policy

Author: Andreas Seiter

Publisher: World Bank Publications

Published: 2010-06-17

Total Pages: 240

ISBN-13: 0821383876

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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.


Pharmaceutical Quality by Design

Pharmaceutical Quality by Design

Author: Walkiria S. Schlindwein

Publisher: John Wiley & Sons

Published: 2018-01-05

Total Pages: 319

ISBN-13: 1118895215

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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.


Research Methods for Pharmaceutical Practice and Policy

Research Methods for Pharmaceutical Practice and Policy

Author: Rajender R. Aparasu

Publisher: Pharmaceutical Press

Published: 2011

Total Pages: 333

ISBN-13: 0853698805

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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.


A Practical Guide to Drug Development in Academia

A Practical Guide to Drug Development in Academia

Author: Daria Mochly-Rosen

Publisher: Springer Science & Business Media

Published: 2014-07-08

Total Pages: 186

ISBN-13: 3319022016

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"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."


Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control

Author: David Roesti

Publisher: John Wiley & Sons

Published: 2020-01-02

Total Pages: 594

ISBN-13: 1119356075

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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


Cost-Effectiveness Analysis in Health

Cost-Effectiveness Analysis in Health

Author: Peter Muennig

Publisher: John Wiley & Sons

Published: 2016-02-03

Total Pages: 561

ISBN-13: 1119011280

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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.


Pharmacovigilance: A Practical Approach

Pharmacovigilance: A Practical Approach

Author: Thao Doan

Publisher: Elsevier Health Sciences

Published: 2018-07-31

Total Pages: 229

ISBN-13: 032358117X

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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. - Covers the evolving regulatory landscape, as well as current and future use of digital technologies. - Uses case studies to ensure content is relevant to everyday practice. - Discusses behavioral science and patient perspectives, risk communication, and new frontiers in pharmacovigilance. - Consolidates today's available information on this timely topic into one convenient resource.


Getting Health Reform Right

Getting Health Reform Right

Author: Marc Roberts

Publisher: Oxford University Press

Published: 2008-04-23

Total Pages: 345

ISBN-13: 0199888167

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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.


Pharmacotherapeutics for Advanced Practice

Pharmacotherapeutics for Advanced Practice

Author: Virginia Poole Arcangelo

Publisher: LWW

Published: 2017

Total Pages: 0

ISBN-13: 9781496319968

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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


Introduction to the Pharmaceutical Sciences

Introduction to the Pharmaceutical Sciences

Author: Nita K. Pandit

Publisher: Lippincott Williams & Wilkins

Published: 2007

Total Pages: 419

ISBN-13: 0781744784

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This unique textbook provides an introductory, yet comprehensive overview of the pharmaceutical sciences. It is the first text of its kind to pursue an interdisciplinary approach in this area of study. Readers are introduced to basic concepts related to the specific disciplines in the pharmaceutical sciences, including pharmacology, pharmaceutics, pharmacokinetics, and medicinal chemistry. In an easy-to-read writing style, the book provides readers with up-to-date information on pharmacogenomics and includes comprehensive coverage of industrial drug development and regulatory approval processes. Each chapter includes chapter outlines and critical-thinking exercises, as well as numerous tables and graphs. More than 160 illustrations complement the text.