The Future of Pharmaceutical Product Development and Research

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Author :
Publisher : Academic Press
ISBN 13 : 0128144556
Total Pages : 974 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis The Future of Pharmaceutical Product Development and Research by :

Download or read book The Future of Pharmaceutical Product Development and Research written by and published by Academic Press. This book was released on 2020-09-02 with total page 974 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 0470942371
Total Pages : 418 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by : Gintaras V. Reklaitis

Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Research and Development in the Pharmaceutical Industry (A CBO Study)

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Author :
Publisher : Lulu.com
ISBN 13 : 1304121445
Total Pages : 65 pages
Book Rating : 4.3/5 (41 download)

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Book Synopsis Research and Development in the Pharmaceutical Industry (A CBO Study) by : Congressional Budget Office

Download or read book Research and Development in the Pharmaceutical Industry (A CBO Study) written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

Improving and Accelerating Therapeutic Development for Nervous System Disorders

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Author :
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 118 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Future of Drug Discovery

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Publisher : Academic Press
ISBN 13 : 0124095194
Total Pages : 376 pages
Book Rating : 4.1/5 (24 download)

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Book Synopsis The Future of Drug Discovery by : Tamas Bartfai

Download or read book The Future of Drug Discovery written by Tamas Bartfai and published by Academic Press. This book was released on 2013-05-18 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Future of Drug Discovery: Who decides which diseases to treat? provides a timely and detailed look at the efforts of the pharmaceutical industry and how they relate, or should relate, to societal needs. The authors posit that as a result of increasing risk aversion and accelerated savings in research and development, the industry is not developing drugs for increasingly prevalent diseases, such as Alzheimer’s disease, untreatable pain, antibiotics and more. This book carefully exposes the gap between the medicines and therapies we need and the current business path. By analyzing the situation and discussing prospects for the next decade, the The Future of Drug Discovery is a timely book for all those who care about the development needs for drugs for disease. Provides an in-depth, broad perspective on the crisis in drug industry Exposes the disconnect between what society needs and what the drug companies are working on Analyses and projects over 10 years into the future Explains what it means for scientists and society Determines what is needed to be done to make sure that the industry responds to society's needs, remains commercially attractive and answers the question as to who decides which diseases to treat

The Changing Economics of Medical Technology

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Publisher : National Academies Press
ISBN 13 : 030904491X
Total Pages : 225 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Pharmaceutical Quality by Design

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Publisher : Academic Press
ISBN 13 : 0128163720
Total Pages : 448 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Pharmaceutical Quality by Design by : Sarwar Beg

Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Contraceptive Research and Development

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Publisher : National Academies Press
ISBN 13 : 0309175658
Total Pages : 534 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Contraceptive Research and Development by : Institute of Medicine

Download or read book Contraceptive Research and Development written by Institute of Medicine and published by National Academies Press. This book was released on 1996-11-04 with total page 534 pages. Available in PDF, EPUB and Kindle. Book excerpt: The "contraceptive revolution" of the 1960s and 1970s introduced totally new contraceptive options and launched an era of research and product development. Yet by the late 1980s, conditions had changed and improvements in contraceptive products, while very important in relation to improved oral contraceptives, IUDs, implants, and injectables, had become primarily incremental. Is it time for a second contraceptive revolution and how might it happen? Contraceptive Research and Development explores the frontiers of science where the contraceptives of the future are likely to be found and lays out criteria for deciding where to make the next R&D investments. The book comprehensively examines today's contraceptive needs, identifies "niches" in those needs that seem most readily translatable into market terms, and scrutinizes issues that shape the market: method side effects and contraceptive failure, the challenge of HIV/AIDS and other sexually transmitted diseases, and the implications of the "women's agenda." Contraceptive Research and Development analyzes the response of the pharmaceutical industry to current dynamics in regulation, liability, public opinion, and the economics of the health sector and offers an integrated set of recommendations for public- and private-sector action to meet a whole new generation of demand.

The Future of Pharma

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Author :
Publisher : Gower Publishing, Ltd.
ISBN 13 : 9781409430315
Total Pages : 224 pages
Book Rating : 4.4/5 (33 download)

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Book Synopsis The Future of Pharma by : Brian David Smith

Download or read book The Future of Pharma written by Brian David Smith and published by Gower Publishing, Ltd.. This book was released on 2011 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Future of Pharma examines the causes of the industry's potential decline and offers a convincing and rigorous analysis of the options open to it. What emerges is a landscape defined, on the one hand, by the changing marketplace of mass-market consumers, institutional healthcare systems and wealthy individuals; and on the other by the alternate sources of commercial value - innovative therapies; super-efficient processes, supply chains and operations; and closer customer relations and increasingly tailored health services.

Medicinal Chemistry with Pharmaceutical Product Development

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Publisher : CRC Press
ISBN 13 : 0429947143
Total Pages : 290 pages
Book Rating : 4.4/5 (299 download)

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Book Synopsis Medicinal Chemistry with Pharmaceutical Product Development by : Debarshi Kar Mahapatra

Download or read book Medicinal Chemistry with Pharmaceutical Product Development written by Debarshi Kar Mahapatra and published by CRC Press. This book was released on 2019-02-04 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume focuses on novel therapeutics and strategies for the development of pharmaceutical products, keeping the drug molecule as the central component. It discusses current theoretical and practical aspects of pharmaceuticals for the discovery and development of novel therapeutics for health problems. Explaining the necessary features essential for pharmacological activity, it takes an interdisciplinary approach by including a unique combination of pharmacy, chemistry, and medicine along with clinical aspects. It takes into consideration the therapeutic regulations of the USP along with all the latest therapeutic guidelines put forward by WHO, and the US Food and Drug Administration.

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

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Author :
Publisher : National Academies Press
ISBN 13 : 0309498511
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Leading Pharmaceutical Innovation

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 3540247815
Total Pages : 178 pages
Book Rating : 4.5/5 (42 download)

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Book Synopsis Leading Pharmaceutical Innovation by : Oliver Gassmann

Download or read book Leading Pharmaceutical Innovation written by Oliver Gassmann and published by Springer Science & Business Media. This book was released on 2013-06-05 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies. The authors focus on three sources of pharmaceutical innovation: new management methods, new technologies, and new forms of internationalization. Their findings are illustrated in the case of the Swiss pharmaceutical industry, the leading exporter of pharmaceutical products in percentage of GDP, and some of its main pharmaceutical firms such as Novartis and Hoffmann-La Roche.

Pharmaceutical Biotechnology

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Publisher : John Wiley & Sons
ISBN 13 : 111868575X
Total Pages : 499 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Pharmaceutical Biotechnology by : Gary Walsh

Download or read book Pharmaceutical Biotechnology written by Gary Walsh and published by John Wiley & Sons. This book was released on 2013-04-25 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

Artificial Intelligence in Drug Discovery

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Publisher : Royal Society of Chemistry
ISBN 13 : 1839160543
Total Pages : 425 pages
Book Rating : 4.8/5 (391 download)

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Book Synopsis Artificial Intelligence in Drug Discovery by : Nathan Brown

Download or read book Artificial Intelligence in Drug Discovery written by Nathan Brown and published by Royal Society of Chemistry. This book was released on 2020-11-04 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following significant advances in deep learning and related areas interest in artificial intelligence (AI) has rapidly grown. In particular, the application of AI in drug discovery provides an opportunity to tackle challenges that previously have been difficult to solve, such as predicting properties, designing molecules and optimising synthetic routes. Artificial Intelligence in Drug Discovery aims to introduce the reader to AI and machine learning tools and techniques, and to outline specific challenges including designing new molecular structures, synthesis planning and simulation. Providing a wealth of information from leading experts in the field this book is ideal for students, postgraduates and established researchers in both industry and academia.

The Future of Pharmaceuticals

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Author :
Publisher : John Wiley & Sons
ISBN 13 :
Total Pages : 168 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Future of Pharmaceuticals by : Clement Bezold

Download or read book The Future of Pharmaceuticals written by Clement Bezold and published by John Wiley & Sons. This book was released on 1981 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Future of Pharmaceutical Product Development and Research

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Author :
Publisher : Academic Press
ISBN 13 : 0128144564
Total Pages : 976 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis The Future of Pharmaceutical Product Development and Research by :

Download or read book The Future of Pharmaceutical Product Development and Research written by and published by Academic Press. This book was released on 2020-08-19 with total page 976 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

Leading Pharmaceutical Innovation

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 3540776362
Total Pages : 186 pages
Book Rating : 4.5/5 (47 download)

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Book Synopsis Leading Pharmaceutical Innovation by : Oliver Gassmann

Download or read book Leading Pharmaceutical Innovation written by Oliver Gassmann and published by Springer Science & Business Media. This book was released on 2008-02-19 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies, aimed at generating sustainable competitive advantage for its protagonists based on value-generating business practices. We focus on three sources of pharmaceutical innovation: new management methods in the drug development pipeline, new technologies as enablers for cutting-edge R&D, and new forms of internationalisation, such as outside-in innovation in the early phases of R&D.