July 6, 2022
Pharmaceutical Medicine and Translational Clinical Research Book

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Pharmaceutical Medicine and Translational Clinical Research

By Divya Vohora,Gursharan Singh
  • ISBN Code: : 0128020989
  • Publisher : Academic Press
  • Pages : 526
  • Category : Medical
  • Reads : 891
  • Book Compatibility : Pdf, ePub, Mobi, Kindle
  • Pdf : pharmaceutical-medicine-and-translational-clinical-research.pdf

Book Excerpt :

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

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Read Also This Books

Drug Stability for Pharmaceutical Scientists

By Thorsteinn Loftsson
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Academic Press
  • Book Code : 0124115624
  • Total of Pages : 170
  • Category : Medical
  • Members : 710
  • Pdf File: drug-stability-for-pharmaceutical-scientists.pdf

Book Short Summary:

Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. This book features valuable content on both aqueous and solid drug solutions, the stability of proteins and peptides, acid-base catalyzed and solvent catalyzed reactions, how drug formulation can influence drug stability, the influence of external factors on reaction rates and much more. Full of examples of real-life formulation problems and step-by-step calculations, this book is the ideal resource for graduate students, as well as scientists in the pharmaceutical and related industries. Illustrates important theoretical concepts with numerous examples, figures, calculations, learning problems and questions for self-study and retention of material Provides answers and explanations to test your knowledge Enables you to better understand key concepts such as rate and order of reaction, reaction equilibrium, complex reaction mechanisms and more Includes an in-depth discussion of both aqueous and solid drug solutions and contains the latest international regulatory requirements on drug stability

Understanding Drugs Markets

By Carine Baxerres,Maurice Cassier
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Routledge
  • Book Code : 1000413101
  • Total of Pages : 320
  • Category : Social Science
  • Members : 166
  • Pdf File: understanding-drugs-markets.pdf

Book Short Summary:

Drawing on anthropology, historical sociology and social-epidemiology, this multidisciplinary book investigates how pharmaceuticals are produced, distributed, prescribed, (and) consumed, and regulated in order to construct a comprehensive understanding of the issues that drive (medicine) pharmaceutical markets in the Global South today. Based on primary research conducted in Benin and Ghana, and additional data collected in Cambodia and the Ivory Coast, this volume uses artemisinin-based combination therapies (ACTs) against malaria as a central case study. It highlights the influence of the countries colonial and post-colonial history on their models for state regulation, production, and distribution, explores the determining role transnational actors as well as industries from the North but also and increasingly from the South play in influencing local pharmaceutical markets and looks at the behaviour of health care professionals and individuals. Stepping back, the authors then unpick the pharmaceuticalization process and the multiple regulations at stake by looking at the workings of, and linkages between, (biomedical health) pharmaceutical systems, (representatives of companies) industries, actors in private distribution, and consumer practices. Providing a thorough comparative analysis of the advantages and disadvantages of different pharmaceutical systems, it is an important contribution to the literature on pharmaceutalization and the governance of medication. It is of interest to students, researchers and policy-makers interested in medical anthropology, the sociology of health and illness, global health, healthcare management and pharmacy. The Open Access version of this book, available at http://www.taylorfrancis.com/books/9780429329517, has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives 4.0 license.

Value Creation in the Pharmaceutical Industry

By Alexander Schuhmacher,Markus Hinder,Oliver Gassmann
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : John Wiley & Sons
  • Book Code : 3527693416
  • Total of Pages : 508
  • Category : Science
  • Members : 368
  • Pdf File: value-creation-in-the-pharmaceutical-industry.pdf

Book Short Summary:

This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.

Medical Monopoly

By Joseph M. Gabriel
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : University of Chicago Press
  • Book Code : 022610821X
  • Total of Pages : 328
  • Category : Medical
  • Members : 651
  • Pdf File: medical-monopoly.pdf

Book Short Summary:

During much of the nineteenth century, physicians and pharmacists alike considered medical patenting and the use of trademarks by drug manufacturers unethical forms of monopoly; physicians who prescribed patented drugs could be, and were, ostracized from the medical community. In the decades following the Civil War, however, complex changes in patent and trademark law intersected with the changing sensibilities of both physicians and pharmacists to make intellectual property rights in drug manufacturing scientifically and ethically legitimate. By World War I, patented and trademarked drugs had become essential to the practice of good medicine, aiding in the rise of the American pharmaceutical industry and forever altering the course of medicine. Drawing on a wealth of previously unused archival material, Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.

The Textbook of Pharmaceutical Medicine

By John P. Griffin
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : John Wiley & Sons
  • Book Code : 9781444317565
  • Total of Pages : 776
  • Category : Business & Economics
  • Members : 102
  • Pdf File: the-textbook-of-pharmaceutical-medicine.pdf

Book Short Summary:

The Textbook of Pharmaceutical Medicine is a standardreference for all those working in pharmaceutical medicine and therecognised text for the UK Faculty of Pharmaceutical MedicineDiploma. This is a comprehensive volume covering the processes bywhich medicines are developed, tested and approved. Regulations fordrug development in the UK, EU, USA, Australia and Japan arediscussed, providing relevant information for drug approval in themain continents where new drugs are developed. The chapters are written by leading academics, medical directorsand lawyers, providing authoritative and in-depth information fortrainees on the Faculty course, and for physicians working in thepharmaceutical industry. As well as thorough updating of theregulatory chapters, the 6th edition includes chapters onthese vital new areas: Paediatric regulation Ethics Due diligence and the pharmaceutical physician

Intellectual Property Law and Access to Medicines

By Srividhya Ragavan,Amaka Vanni
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Routledge
  • Book Code : 1000398706
  • Total of Pages : 522
  • Category : Law
  • Members : 181
  • Pdf File: intellectual-property-law-and-access-to-medicines.pdf

Book Short Summary:

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors – states, transnational business corporations, or civil society groups – and their influence on the structures – such as national and international agreements, organizations, and private entities – that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

Brand Medicine

By T. Blackett,R. Robins
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer
  • Book Code : 0230522513
  • Total of Pages : 308
  • Category : Business & Economics
  • Members : 951
  • Pdf File: brand-medicine.pdf

Book Short Summary:

As governments seek to mitigate the cost of state-subsidised healthcare, branding in the pharmaceutical industry has become a critical issue. Drugs companies must change their methods of communication and distribution - focusing more on their direct relationship with the consumer. This requires fundamental changes in consumer behaviour, access to information, freedom of choice and value for money. Brands and brand values will play a leading role in this process, as has been seen with products such as Prozac and Viagra. This book by Interbrand Newell and Sorrell, the world's leading branding consultancy, provides cutting edge thinking on this area and lessons for anyone involved in brand development and management.

Deadly Medicines and Organised Crime

By Peter Gotzsche
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Book Code : 1908911123
  • Total of Pages : 322
  • Category : Medical
  • Members : 557
  • Pdf File: deadly-medicines-and-organised-crime.pdf

Book Short Summary:

PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the pharmaceutical industries and their charade of fraudulent behaviour, both in research and marketing where the morally repugnant disregard for human lives is the norm. He convincingly draws close co

Pharmaceutical Systems

By John Lilja,Sam Salek,Aldo Alvarez,David Hamilton
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : John Wiley & Sons
  • Book Code : 0470754044
  • Total of Pages : 356
  • Category : Medical
  • Members : 623
  • Pdf File: pharmaceutical-systems.pdf

Book Short Summary:

Offers a social view of the activities leading to the timely patient access to medicines including: drug research, drug production, drug distribution, drug prescribing, drug information and drug control Provides theoretical models to enable pharmacists to understand the organization of drug systems in their particular global territory Written specifically with the needs of pharmacy students taking Master's degrees in mind

Strong Medicine

By Michael Kremer,Rachel Glennerster
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Princeton University Press
  • Book Code : 1400880149
  • Total of Pages : 152
  • Category : Business & Economics
  • Members : 217
  • Pdf File: strong-medicine.pdf

Book Short Summary:

From Nobel Prize–winning economist Michael Kremer and fellow leading development economist Rachel Glennerster, an innovative solution for providing vaccines in poor countries Millions of people in the third world die from diseases that are rare in the first world—diseases like malaria, tuberculosis, and schistosomiasis. AIDS, which is now usually treated in rich countries, still ravages the world's poor. Vaccines offer the best hope for controlling these diseases and could dramatically improve health in poor countries. But developers have little incentive to undertake the costly and risky research needed to develop vaccines. This is partly because the potential consumers are poor, but also because governments drive down prices. In Strong Medicine, Michael Kremer and Rachel Glennerster offer an innovative yet simple solution to this worldwide problem: "Pull" programs to stimulate research. Here's how such programs would work. Funding agencies would commit to purchase viable vaccines if and when they were developed. This would create the incentives for vaccine developers to produce usable products for these neglected diseases. Private firms, rather than funding agencies, would pick which research strategies to pursue. After purchasing the vaccine, funders could distribute it at little or no cost to the afflicted countries. Strong Medicine details just how these legally binding commitments would work. Ultimately, if no vaccines were developed, such a commitment would cost nothing. But if vaccines were developed, the program would save millions of lives and would be among the world's most cost-effective health interventions.

Access to Medicines as a Human Right

By Lisa Forman,Jillian Clare Kohler
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : University of Toronto Press
  • Book Code : 1442661127
  • Total of Pages : 240
  • Category : Medical
  • Members : 221
  • Pdf File: access-to-medicines-as-a-human-right.pdf

Book Short Summary:

According to the World Health Organization, one-third of the global population lacks access to essential medicines. Should pharmaceutical companies be ethically or legally responsible for providing affordable medicines for these people, even though they live outside of profitable markets? Can the private sector be held accountable for protecting human beings' right to health? This thought-provoking interdisciplinary collection grapples with corporate responsibility for the provision of medicines in low- and middle-income countries. The book begins with an examination of human rights, norms, and ethics in relation to the private sector, moving to consider the tensions between pharmaceutical companies' social and business duties. Broad examinations of global conditions are complemented by case studies illustrating different approaches for addressing corporate conduct. Access to Medicines as a Human Right identifies innovative solutions applicable in both global and domestic forums, making it a valuable resource for the vast field of scholars, legal practitioners, and policymakers who must confront this challenging issue.

Pharmaceutical Ethics

By Sam Salek,Andrew Edgar
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : John Wiley & Sons
  • Book Code : 0470855819
  • Total of Pages : 210
  • Category : Medical
  • Members : 177
  • Pdf File: pharmaceutical-ethics.pdf

Book Short Summary:

Pharmaceutical Ethics is an important text, which aims to provide the ethical guidelines much needed by the pharmaceutical industry. By focusing on many of the central issues such as the ethical aspects of clinical trials, informed consent, physician or patient choice and pharmaceutical advertising, this text will provide very good coverage of an area which perhaps still lacks coherent instruction. * Covers ethical issues involved in the testing and use of pharmaceuticals on human beings * Investigates issues such as whether choice of drug should lie with the physician or the patient * Looks at a wide variety of subjects connected with pharmaceutical ethics. * Focuses specifically on the issues surrounding the pharmaceutical industry, not medicine in general. * Fulfils an important need in the Pharmaceutical Industry.

Conflict of Interest in Medical Research, Education, and Practice

By Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : National Academies Press
  • Book Code : 0309145449
  • Total of Pages : 436
  • Category : Medical
  • Members : 875
  • Pdf File: conflict-of-interest-in-medical-research-education-and-practice.pdf

Book Short Summary:

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.

An Introduction to Pharmaceutical Sciences

By Jiben Roy
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Elsevier
  • Book Code : 1908818042
  • Total of Pages : 446
  • Category : Medical
  • Members : 197
  • Pdf File: an-introduction-to-pharmaceutical-sciences.pdf

Book Short Summary:

This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences. This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry. A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry. Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries

Drugs & Pharmaceutical Technology Handbook

By NIIR Board
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : ASIA PACIFIC BUSINESS PRESS Inc.
  • Book Code : 8178330547
  • Total of Pages : 636
  • Category :
  • Members : 541
  • Pdf File: drugs-pharmaceutical-technology-handbook.pdf

Book Short Summary:

Drugs and pharmaceutical industry plays a vital role in the economic development of a nation. It is one of the largest and most advanced sectors in the world, acting as a source for various drugs, medicines and their intermediates as well as other pharmaceutical formulations. India has come a long way in this field, from a country importing more than 95% of its requirement of drugs and pharmaceuticals; India now is exporting it even to developed countries. Being the intense knowledge driven industry, it offers innumerable business opportunities for the investors/ corporate the world over. The existence of well defined and strong pharmaceutical industry is important for promoting and sustaining research and developmental efforts and initiatives in an economy as well as making available the quality medicines to all at affordable prices. That is, it is essential to improve the health status of the individuals as well as the society as a whole, so that positive contributions could be made to the economic growth and regional development of a country. On the global platform, India holds fourth position in terms of volume and thirteenth position in terms of value of production in pharmaceuticals. The pharmaceutical industry has been producing bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing processes as well as a wide range of pharmaceutical machinery and equipments. The modern Indian Pharmaceutical Industry is recent and its foundation was laid in the beginning of the current century. The pharmaceutical industry can be broadly categorised as bulk drugs, formulations, IV fluids and pharmaceutical aids (such as medical equipment, hospital disposables, capsules, etc.). Special feature of the pharmaceutical industry is a large number of manufacturers in the small scale sector. The government is also encouraging the SSI sector providing some incentives. The recent developments in the technology and R & D work in this field have led to the increased growth rate of industries and have established Indian Pharmaceutical industries in the international market. The content of the book includes information about properties, general methods of analysis, methods of manufacture, of different types of drugs and pharmaceuticals. Some of the fundamentals of the book are polymeric materials used in drug delivery systems , theoretical aspects of friction and lubrication , a convenient method for conversion of quinine to quinidine, formulation and evaluation of bio-available enteric-coated erythromycin and metronidazole tablets, extraction of virginiamycin, antipyretics and analgesics, column chromatographic assay of aspirin tablets, differentiating titration of phenacetin and caffeine, infrared spectra of some compounds of pharmaceutical interest etc. This book covers an intensive study on manufacturing, production, formulation and quality control of drugs and pharmaceuticals with technology involved in it. This book is an invaluable resource for technologists, professionals and those who want to venture in this field.

Institutional Corruption Theory in Pharmaceutical Industry-Medicine Relationships

By Anna Laskai
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Nature
  • Book Code : 3030447901
  • Total of Pages : 290
  • Category : Social Science
  • Members : 361
  • Pdf File: institutional-corruption-theory-in-pharmaceutical-industry-medicine-relationships.pdf

Book Short Summary:

​This book discusses the influence of the pharmaceutical industry on the practice of medicine, and the observed and potential pitfalls of such partnerships. It argues that the pharmaceutical industry has become indispensable to many of the activities of the medical profession across the pharmaceutical product lifecycle, and examines the regulatory, ethical, professional and institutional difficulties that arise from these interactions. With data drawn from over 80 qualitative accounts from medical, pharmaceutical, regulatory and healthcare professionals, this book uses both Hungary and the Netherlands as case studies to demonstrate the potential problem of undue pharmaceutical industry influence within the relationships fostered with the profession of medicine. Chapters systematically describe the lifecycle of a pharmaceutical product from research to distribution, demonstrating the interdependency of industry and medicine. Arguing that the medical profession should be a buffer between the pharmaceutical industry interests and patient interests, the book explores how undue industry influence weakens the ability of the medical profession to do so. Using the theory of institutional corruption, the book aims to analyze how conflict of interest and the weakening of institutional imperatives is a result of institutional interactions rather than individual actions. Appropriate for students and researchers of the pharmaceutical industry, corporate corruption, and those working in NGOs and policy making, this unique volume is an comprehensive look at the complex relationship between medicine and pharmacy.

Equitable Access to High-Cost Pharmaceuticals

By Zaheer-Ud-Din Babar
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Academic Press
  • Book Code : 0128119624
  • Total of Pages : 238
  • Category : Business & Economics
  • Members : 834
  • Pdf File: equitable-access-to-high-cost-pharmaceuticals.pdf

Book Short Summary:

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

Benefit-Risk Appraisal of Medicines

By Filip Mussen,Sam Salek,Stuart Walker
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : John Wiley & Sons
  • Book Code : 0470748125
  • Total of Pages : 304
  • Category : Medical
  • Members : 844
  • Pdf File: benefit-risk-appraisal-of-medicines.pdf

Book Short Summary:

Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall appraisal of benefits and risks of medicines. Benefit-Risk Appraisal of Medicines establishes the background and criteria required to assess benefit and risk in general and reviews the current practices by regulatory authorities and the pharmaceutical industry, including those models currently available. It outlines the development and evaluation of the authors’ new model and analyses the implications of its implementation. Describes an innovative, systematic model which leads to transparent and responsible benefit-risk decision making Contributes important ideas to the debate on benefit-risk appraisal Provides a future framework for benefit-risk appraisal of medicines Benefit-Risk Appraisal of Medicines covers the entire process from the discovery of new medicines to their marketing and is ideal for all those who work in the pharmaceutical industry and regulatory authorities,, as well as post-graduate students of pharmaceutical medicine and clinical pharmacology.

Leadership in the Life Sciences

By Brian D. Smith
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Routledge
  • Book Code : 0429663773
  • Total of Pages : 92
  • Category : Business & Economics
  • Members : 232
  • Pdf File: leadership-in-the-life-sciences.pdf

Book Short Summary:

The healthcare professionals who save and extend our lives are helpless without the medicines and technologies that have revolutionised medical care. But the industry that invents, makes and provides these indispensable tools is transforming under the pressure of ageing populations, globalisation and revolutions in biological and information technology. How this industry adapts and evolves is vitally important to every one of us. This book looks inside the heads and hearts of the people who lead the global pharmaceutical and medical technology industry. It describes how they make sense of their markets and the wider life sciences economy. It reveals what they have learned about how to lead large, complex organisations to compete in dynamic, global markets. Leadership in the Life Sciences is essential reading for anyone working in or with the pharmaceutical and medical technology industry and its halo of supporting companies. Written as ten succinct lessons, it gives the reader unique insight into what the industry’s leaders are thinking. Covering topics from leadership to organisational culture, from change management to digital disruption and from competitive strategy to value-creation, each chapter distils the accumulated wisdom of those who lead the complex and turbulent life sciences industry.

Pain Management and the Opioid Epidemic

By National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : National Academies Press
  • Book Code : 0309459575
  • Total of Pages : 482
  • Category : Medical
  • Members : 353
  • Pdf File: pain-management-and-the-opioid-epidemic.pdf

Book Short Summary:

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Making Medicines in Africa

By Maureen Mackintosh,Geoffrey Banda,Watu Wamae,Paula Tibandebage
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer
  • Book Code : 1137546476
  • Total of Pages : 334
  • Category : Political Science
  • Members : 678
  • Pdf File: making-medicines-in-africa.pdf

Book Short Summary:

This book is open access under a CC-BY license. The importance of the pharmaceutical industry in Sub-Saharan Africa, its claim to policy priority, is rooted in the vast unmet health needs of the sub-continent. Making Medicines in Africa is a collective endeavour, by a group of contributors with a strong African and more broadly Southern presence, to find ways to link technological development, investment and industrial growth in pharmaceuticals to improve access to essential good quality medicines, as part of moving towards universal access to competent health care in Africa. The authors aim to shift the emphasis in international debate and initiatives towards sustained Africa-based and African-led initiatives to tackle this huge challenge. Without the technological, industrial, intellectual, organisational and research-related capabilities associated with competent pharmaceutical production, and without policies that pull the industrial sectors towards serving local health needs, the African sub-continent cannot generate the resources to tackle its populations' needs and demands. Research for this book has been selected as one of the 20 best examples of the impact of UK research on development. See http://www.ukcds.org.uk/the-global-impact-of-uk-research for further details.

Pharmaceutical Regulatory Environment

By Reem K. Al-Essa,Mohammed Al-Rubaie,Stuart Walker,Sam Salek
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer
  • Book Code : 3319175904
  • Total of Pages : 236
  • Category : Medical
  • Members : 191
  • Pdf File: pharmaceutical-regulatory-environment.pdf

Book Short Summary:

This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

Bottle of Lies

By Katherine Eban
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : HarperCollins
  • Book Code : 0063054108
  • Total of Pages : 512
  • Category : Medical
  • Members : 129
  • Pdf File: bottle-of-lies.pdf

Book Short Summary:

A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 New postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.

The Quality Control of Medicines

By P.B. Deasy,R.F. Timoney
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Elsevier
  • Book Code : 1483165027
  • Total of Pages : 412
  • Category : Medical
  • Members : 187
  • Pdf File: the-quality-control-of-medicines.pdf

Book Short Summary:

The Quality Control of Medicines documents the proceedings of the 35th International Congress of Pharmaceutical Sciences, organized by the Pharmaceutical Society of Ireland on behalf of the Federation Internationale Pharmaceutique, held in Dublin, on 1-5 September 1975. The theme chosen for the Congress was ""the basis for the quality control of medicines"", because of the importance and relevance of quality control in the production and distribution of medicines at national and international levels. This volume is arranged according to the manner in which the theme of the Congress was developed by the eminent invited speakers. Following the inaugural address a main symposium was held where five speakers presented a review of the quality control of medicines under the general headings of (i) chemical and physical aspects; (ii) biological aspects; (iii) control of drug delivery systems; (iv) storage problems; and (v) problems of international control. Certain aspects of the content of the main symposium were then developed in greater depth in parallel symposia. In the first parallel symposium some novel physicochemical aspects of the quality control of medicines were treated under the headings of spectrofluorimetry, mass spectrometry, detection in gas chromatography, and automation in pharmaceutical analysis. The second parallel symposium developed certain microbiological aspects of quality control under the headings of sterility testing and microbiological control of non-sterile products and ophthalmic preparations. The final symposium on submissions to regulatory bodies and international aspects of drug control covered aspects of politics in submissions, regulatory problems in small countries, and various pharmacopoeial problems.

OECD Health Policy Studies Pharmaceutical Innovation and Access to Medicines

By OECD
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : OECD Publishing
  • Book Code : 9264307397
  • Total of Pages : 192
  • Category :
  • Members : 688
  • Pdf File: oecd-health-policy-studies-pharmaceutical-innovation-and-access-to-medicines.pdf

Book Short Summary:

This report reviews the important role of medicines in health sytems, describes recent trends in pharmaceutical expenditure and financing, and summarises the approaches used by OECD countries to determine coverage and pricing.

The Context of Medicines in Developing Countries

By Sjaak van der Geest,Susan Reynolds Whyte
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Science & Business Media
  • Book Code : 9400927134
  • Total of Pages : 393
  • Category : Social Science
  • Members : 273
  • Pdf File: the-context-of-medicines-in-developing-countries.pdf

Book Short Summary:

Western pharmaceuticals are flooding the Third World. Injections, capsules and tablets are available in city markets and village shops, from 'traditional' practitioners and street vendors, as well as from more orthodox sources like hospitals. Although many are aware of this 'pharmaceutical invasion', little has been written about how local people perceive and use these products. This book is a first attempt to remedy that situation. It presents studies of the ways Western medicines are circulated and understood in the cities and rural areas of Africa, Asia and Latin America. We feel that such a collection is long overdue for two reasons. The first is a practical one: people dealing with health problems in developing countries need information about local situations and they need examples of methods they can use to examine the particular contexts in which they are working. We hope that this book will be useful for pharmacists, doctors, nurses, health planners, policy makers and concerned citizens, who are interested in the realities of drug use. Why do people want various kinds of medicine? How do they evaluate and choose them and how do they obtain them? The second reason for these studies of medicines is to fill a need in medical anthropology as a field of study. Here we address our colleagues in anthropol ogy, medical sociology and related disciplines.

Pharmaceutical Biotechnology

By Oliver Kayser,Heribert Warzecha
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : John Wiley & Sons
  • Book Code : 352765125X
  • Total of Pages : 676
  • Category : Science
  • Members : 828
  • Pdf File: pharmaceutical-biotechnology.pdf

Book Short Summary:

This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.

Herbal Medicine

By Iris F. F. Benzie,Sissi Wachtel-Galor
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Book Code : 1439807167
  • Total of Pages : 500
  • Category : Health & Fitness
  • Members : 736
  • Pdf File: herbal-medicine.pdf

Book Short Summary:

The global popularity of herbal supplements and the promise they hold in treating various disease states has caused an unprecedented interest in understanding the molecular basis of the biological activity of traditional remedies. Herbal Medicine: Biomolecular and Clinical Aspects focuses on presenting current scientific evidence of biomolecular ef

Pharmaceutical Drug Product Development and Process Optimization

By Sarwar Beg,Majed Al Robaian,Mahfoozur Rahman,Syed Sarim Imam,Nabil Alruwaili,Sunil Kumar Panda
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Book Code : 1000731324
  • Total of Pages : 354
  • Category : Business & Economics
  • Members : 196
  • Pdf File: pharmaceutical-drug-product-development-and-process-optimization.pdf

Book Short Summary:

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

Regulatory Affairs in the Pharmaceutical Industry

By Javed Ali,Sanjula Baboota
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Academic Press
  • Book Code : 0128222239
  • Total of Pages : 286
  • Category : Medical
  • Members : 756
  • Pdf File: regulatory-affairs-in-the-pharmaceutical-industry.pdf

Book Short Summary:

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

Transparency, Power, and Influence in the Pharmaceutical Industry

By Katherine Fierlbeck,Janice Graham,Matthew Herder
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : University of Toronto Press
  • Book Code : 1487529066
  • Total of Pages : 304
  • Category : Medical
  • Members : 847
  • Pdf File: transparency-power-and-influence-in-the-pharmaceutical-industry.pdf

Book Short Summary:

There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to ensure that the economic success of the industry does not come at the expense of public safety, yet they have also assumed a cooperative role by providing advice on regulation and by targeting unmet medical needs. Concerns over regulatory standards, conflicts of interest, and the manipulation of information on drug safety and effectiveness have led to public mistrust and a greater need for transparency between the pharmaceutical industry and government regulators. Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry responsible for creating transparency in the industry, from development to market. The contributors to this volume examine the various mechanisms introduced to make the regulatory process more informative and situate these efforts within the larger project of enhancing the safety of drugs, vaccines, and other products.