Author: Purusotam Basnet
Publisher: BoD – Books on Demand
ISBN: 9535106317
Category : Business & Economics
Languages : en
Pages : 162
Book Description
From the dawn of civilization, humans have been dreaming of happy, healthy and long-life. Our life expectancy is twice longer than 100 years ago. We know more about the diseases. Therefore we have developed new drugs to fight against them. The demand for drugs was so high that we developed Pharma industries. Although Pharma industries took responsibility of producing the needed drugs and gave us a quality of life, misuse of drugs brought further complication. Therefore, discovery, production, distribution, and the phase of administration of patients' quality assurance has to be controlled with a technological procedure and tight regulations to make the system as effective as possible for the benefit of human health. Our book provides selected but vital information on the sources, tools, technologies and regulations regarding the current status of medicine development.
Promising Pharmaceuticals
Author: Purusotam Basnet
Publisher: BoD – Books on Demand
ISBN: 9535106317
Category : Business & Economics
Languages : en
Pages : 162
Book Description
From the dawn of civilization, humans have been dreaming of happy, healthy and long-life. Our life expectancy is twice longer than 100 years ago. We know more about the diseases. Therefore we have developed new drugs to fight against them. The demand for drugs was so high that we developed Pharma industries. Although Pharma industries took responsibility of producing the needed drugs and gave us a quality of life, misuse of drugs brought further complication. Therefore, discovery, production, distribution, and the phase of administration of patients' quality assurance has to be controlled with a technological procedure and tight regulations to make the system as effective as possible for the benefit of human health. Our book provides selected but vital information on the sources, tools, technologies and regulations regarding the current status of medicine development.
Publisher: BoD – Books on Demand
ISBN: 9535106317
Category : Business & Economics
Languages : en
Pages : 162
Book Description
From the dawn of civilization, humans have been dreaming of happy, healthy and long-life. Our life expectancy is twice longer than 100 years ago. We know more about the diseases. Therefore we have developed new drugs to fight against them. The demand for drugs was so high that we developed Pharma industries. Although Pharma industries took responsibility of producing the needed drugs and gave us a quality of life, misuse of drugs brought further complication. Therefore, discovery, production, distribution, and the phase of administration of patients' quality assurance has to be controlled with a technological procedure and tight regulations to make the system as effective as possible for the benefit of human health. Our book provides selected but vital information on the sources, tools, technologies and regulations regarding the current status of medicine development.
Bad Pharma
Author: Ben Goldacre
Publisher: Macmillan
ISBN: 0865478066
Category : Business & Economics
Languages : en
Pages : 479
Book Description
Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
Publisher: Macmillan
ISBN: 0865478066
Category : Business & Economics
Languages : en
Pages : 479
Book Description
Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
Improving and Accelerating Therapeutic Development for Nervous System Disorders
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309292492
Category : Medical
Languages : en
Pages : 107
Book Description
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Publisher: National Academies Press
ISBN: 0309292492
Category : Medical
Languages : en
Pages : 107
Book Description
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
The Truth About the Drug Companies
Author: Marcia Angell
Publisher: Random House Trade Paperbacks
ISBN: 0375760946
Category : Business & Economics
Languages : en
Pages : 354
Book Description
During her two decades at The New England Journal of Medicine, Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book, Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become–and argues for essential, long-overdue change. Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers. Zeroing in on hugely successful drugs like AZT (the first drug to treat HIV/AIDS), Taxol (the best-selling cancer drug in history), and the blockbuster allergy drug Claritin, Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective. The American pharmaceutical industry needs to be saved, mainly from itself, and Dr. Angell proposes a program of vital reforms, which includes restoring impartiality to clinical research and severing the ties between drug companies and medical education. Written with fierce passion and substantiated with in-depth research, The Truth About the Drug Companies is a searing indictment of an industry that has spun out of control.
Publisher: Random House Trade Paperbacks
ISBN: 0375760946
Category : Business & Economics
Languages : en
Pages : 354
Book Description
During her two decades at The New England Journal of Medicine, Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book, Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become–and argues for essential, long-overdue change. Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers. Zeroing in on hugely successful drugs like AZT (the first drug to treat HIV/AIDS), Taxol (the best-selling cancer drug in history), and the blockbuster allergy drug Claritin, Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective. The American pharmaceutical industry needs to be saved, mainly from itself, and Dr. Angell proposes a program of vital reforms, which includes restoring impartiality to clinical research and severing the ties between drug companies and medical education. Written with fierce passion and substantiated with in-depth research, The Truth About the Drug Companies is a searing indictment of an industry that has spun out of control.
Synthesis of Best-Seller Drugs
Author: Ruben Vardanyan
Publisher: Academic Press
ISBN: 0124115241
Category : Medical
Languages : en
Pages : 870
Book Description
Synthesis of Best-Seller Drugs is a key reference guide for all those involved with the design, development, and use of the best-selling drugs. Designed for ease of use, this book provides detailed information on the most popular drugs, using a practical layout arranged according to drug type. Each chapter reviews the main drugs in each of nearly 40 key therapeutic areas, also examining their classification, novel structural features, models of action, and synthesis. Of high interest to all those who work in the captivating areas of biologically active compounds and medicinal drug synthesis, in particular medicinal chemists, biochemists, and pharmacologists, the book aims to support current research efforts, while also encouraging future developments in this important field. - Describes methods of synthesis, bioactivity and related drugs in key therapeutic areas - Reviews the main drugs in each of nearly 40 key therapeutic areas, also examining their classification, novel structural features, models of action, and more - Presents a practical layout designed for use as a quick reference tool by those working in drug design, development and implementation
Publisher: Academic Press
ISBN: 0124115241
Category : Medical
Languages : en
Pages : 870
Book Description
Synthesis of Best-Seller Drugs is a key reference guide for all those involved with the design, development, and use of the best-selling drugs. Designed for ease of use, this book provides detailed information on the most popular drugs, using a practical layout arranged according to drug type. Each chapter reviews the main drugs in each of nearly 40 key therapeutic areas, also examining their classification, novel structural features, models of action, and synthesis. Of high interest to all those who work in the captivating areas of biologically active compounds and medicinal drug synthesis, in particular medicinal chemists, biochemists, and pharmacologists, the book aims to support current research efforts, while also encouraging future developments in this important field. - Describes methods of synthesis, bioactivity and related drugs in key therapeutic areas - Reviews the main drugs in each of nearly 40 key therapeutic areas, also examining their classification, novel structural features, models of action, and more - Presents a practical layout designed for use as a quick reference tool by those working in drug design, development and implementation
Science Business
Author: Gary P. Pisano
Publisher: Harvard Business Press
ISBN: 9781591398400
Category : Business & Economics
Languages : en
Pages : 278
Book Description
Why has the biotechnology industry failed to perform up to expectations? This book attempts to answer this question by providing a critique of the industry. It reveals the causes of biotech's problems and offers an analysis on how the industry works. It also provides prescriptions for companies, seeking ways to improve the industry's performance.
Publisher: Harvard Business Press
ISBN: 9781591398400
Category : Business & Economics
Languages : en
Pages : 278
Book Description
Why has the biotechnology industry failed to perform up to expectations? This book attempts to answer this question by providing a critique of the industry. It reveals the causes of biotech's problems and offers an analysis on how the industry works. It also provides prescriptions for companies, seeking ways to improve the industry's performance.
Drug Discovery and Development - E-Book
Author: Raymond G Hill
Publisher: Elsevier Health Sciences
ISBN: 0702053163
Category : Medical
Languages : en
Pages : 361
Book Description
The modern pharmacopeia has enormous power to alleviate disease, and owes its existence almost entirely to the work of the pharmaceutical industry. This book provides an introduction to the way the industry goes about the discovery and development of new drugs. The first part gives a brief historical account from its origins in the mediaeval apothecaries' trade, and discusses the changing understanding of what we mean by disease, and what therapy aims to achieve, as well as summarising case histories of the discovery and development of some important drugs. The second part focuses on the science and technology involved in the discovery process: the stages by which a promising new chemical entity is identified, from the starting point of a medical need and an idea for addressing it. A chapter on biopharmaceuticals, whose discovery and development tend to follow routes somewhat different from synthetic compounds, is included here, as well as accounts of patent issues that arise in the discovery phase, and a chapter on research management in this environment. The third section of the book deals with drug development: the work that has to be undertaken to turn the drug candidate that emerges from the discovery process into a product on the market. - The definitive introduction to how a pharmaceutical company goes about its business of discovering and developing drugs. The second edition has a new editor: Professor Raymond Hill ● non-executive director of Addex Pharmaceuticals, Covagen and of Orexo AB ● Visiting Industrial Professor of Pharmacology in the University of Bristol ● Visiting Professor in the School of Medical and Health Sciences at the University of Surrey ● Visiting Professor in Physiology and Pharmacology at the University of Strathclyde ● President and Chair of the Council of the British Pharmacological Society ● member of the Nuffield Council on Bioethics and the Advisory Council on Misuse of Drugs. New to this edition: - Completely rewritten chapter on The Role of Medicinal Chemistry in the Drug Discovery Process. - New topic - DMPK Optimization Strategy in drug discovery. - New chapter on Scaffolds: Small globular proteins as antibody substitutes. - Totally updated chapters on Intellectual Property and Marketing - 50 new illustrations in full colour Features - Accessible, general guide to pharmaceutical research and development. - Examines the interfaces between cost and social benefit, quality control and mass production, regulatory bodies, patent management, and all interdisciplinary intersections essential to effective drug development. - Written by a strong team of scientists with long experience in the pharmaceutical industry. - Solid overview of all the steps from lab bench to market in an easy-to-understand way which will be accessible to non-specialists. From customer reviews of the previous edition: '... it will have everything you need to know on this module. Deeply referenced and, thus, deeply reliable. - Highly Commended in the medicine category of the BMA 2006 medical book competition - Winner of the Royal Society of Medicine Library Prize for Medical Book of the Year
Publisher: Elsevier Health Sciences
ISBN: 0702053163
Category : Medical
Languages : en
Pages : 361
Book Description
The modern pharmacopeia has enormous power to alleviate disease, and owes its existence almost entirely to the work of the pharmaceutical industry. This book provides an introduction to the way the industry goes about the discovery and development of new drugs. The first part gives a brief historical account from its origins in the mediaeval apothecaries' trade, and discusses the changing understanding of what we mean by disease, and what therapy aims to achieve, as well as summarising case histories of the discovery and development of some important drugs. The second part focuses on the science and technology involved in the discovery process: the stages by which a promising new chemical entity is identified, from the starting point of a medical need and an idea for addressing it. A chapter on biopharmaceuticals, whose discovery and development tend to follow routes somewhat different from synthetic compounds, is included here, as well as accounts of patent issues that arise in the discovery phase, and a chapter on research management in this environment. The third section of the book deals with drug development: the work that has to be undertaken to turn the drug candidate that emerges from the discovery process into a product on the market. - The definitive introduction to how a pharmaceutical company goes about its business of discovering and developing drugs. The second edition has a new editor: Professor Raymond Hill ● non-executive director of Addex Pharmaceuticals, Covagen and of Orexo AB ● Visiting Industrial Professor of Pharmacology in the University of Bristol ● Visiting Professor in the School of Medical and Health Sciences at the University of Surrey ● Visiting Professor in Physiology and Pharmacology at the University of Strathclyde ● President and Chair of the Council of the British Pharmacological Society ● member of the Nuffield Council on Bioethics and the Advisory Council on Misuse of Drugs. New to this edition: - Completely rewritten chapter on The Role of Medicinal Chemistry in the Drug Discovery Process. - New topic - DMPK Optimization Strategy in drug discovery. - New chapter on Scaffolds: Small globular proteins as antibody substitutes. - Totally updated chapters on Intellectual Property and Marketing - 50 new illustrations in full colour Features - Accessible, general guide to pharmaceutical research and development. - Examines the interfaces between cost and social benefit, quality control and mass production, regulatory bodies, patent management, and all interdisciplinary intersections essential to effective drug development. - Written by a strong team of scientists with long experience in the pharmaceutical industry. - Solid overview of all the steps from lab bench to market in an easy-to-understand way which will be accessible to non-specialists. From customer reviews of the previous edition: '... it will have everything you need to know on this module. Deeply referenced and, thus, deeply reliable. - Highly Commended in the medicine category of the BMA 2006 medical book competition - Winner of the Royal Society of Medicine Library Prize for Medical Book of the Year
Promising Drug Molecules of Natural Origin
Author: Rohit Dutt
Publisher: CRC Press
ISBN: 1000765156
Category : Science
Languages : en
Pages : 481
Book Description
This new volume, Promising Drug Molecules of Natural Origin, explores potential beneficial drug substances derived from nature. It presents the general principles, characteristics, evaluation techniques, and applications involved in drug molecules from natural sources, such as plants and marine life. With chapters from renowned experts from around the world, the chapters in this volume address the challenges of standardization of herbal medicines, methods of characterization of natural medicines and phyto-constituents, and quality control methods for herbal medicines. Several chapters in the book focus on the evolution of phyto-constituents in cancer therapeutics, while others deal with applications for other diseases, such as diabetes and neuroinflammatory disorders. The volume also specifically reviews heterocyclic drugs from plants. This volume will be a valuable resource for faculty and advanced students in pharmaceutics as well as researchers, scientists, and industry professionals in medicine and drug development.
Publisher: CRC Press
ISBN: 1000765156
Category : Science
Languages : en
Pages : 481
Book Description
This new volume, Promising Drug Molecules of Natural Origin, explores potential beneficial drug substances derived from nature. It presents the general principles, characteristics, evaluation techniques, and applications involved in drug molecules from natural sources, such as plants and marine life. With chapters from renowned experts from around the world, the chapters in this volume address the challenges of standardization of herbal medicines, methods of characterization of natural medicines and phyto-constituents, and quality control methods for herbal medicines. Several chapters in the book focus on the evolution of phyto-constituents in cancer therapeutics, while others deal with applications for other diseases, such as diabetes and neuroinflammatory disorders. The volume also specifically reviews heterocyclic drugs from plants. This volume will be a valuable resource for faculty and advanced students in pharmaceutics as well as researchers, scientists, and industry professionals in medicine and drug development.
Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Equitable Access to High-Cost Pharmaceuticals
Author: Zaheer-Ud-Din Babar
Publisher: Academic Press
ISBN: 0128119624
Category : Medical
Languages : en
Pages : 240
Book Description
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
Publisher: Academic Press
ISBN: 0128119624
Category : Medical
Languages : en
Pages : 240
Book Description
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