The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research
Author: Anonim
Publsiher: Academic Press
Total Pages: 976
Release: 2020-08-19
ISBN 10: 0128144564
ISBN 13: 9780128144565
Language: EN, FR, DE, ES & NL

The Future of Pharmaceutical Product Development and Research Book Review:

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

Pharmaceutical Product Development

Pharmaceutical Product Development
Author: Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee
Publsiher: CRC Press
Total Pages: 428
Release: 2016-02-24
ISBN 10: 9781498730778
ISBN 13: 1498730779
Language: EN, FR, DE, ES & NL

Pharmaceutical Product Development Book Review:

The field of pharmaceutical product development has undergone a significant change over the years, from an early phase of adopting mostly empirical and unsubstantiated approaches, to a focus on a more structured process that contributes to the essential and allied processes involved in creating a finished product. This book seeks to disseminate the knowledge for pharmaceutical product development in an easy-to-read mode with simplified theories, case studies and guidelines for both students and professionals in the pharmaceutical industry. Introduction to recent quality improvement trends such as quality metricsand continuous manufacturing are also provided.

The Future of Drug Discovery

The Future of Drug Discovery
Author: Tamas Bartfai,Graham V. Lees
Publsiher: Academic Press
Total Pages: 346
Release: 2013
ISBN 10: 9780124071803
ISBN 13: 0124071805
Language: EN, FR, DE, ES & NL

The Future of Drug Discovery Book Review:

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. This thought-provoking book is the first to: • provide an in-depth, broad perspective on the crisis in drug industry • expose the disconnect between what society needs and what the drug companies are working on • analyse and project over 10 years into the future • explain what it means for scientists and society • determine 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

Dosage Form Design Parameters

Dosage Form Design Parameters
Author: Anonim
Publsiher: Academic Press
Total Pages: 810
Release: 2018-07-25
ISBN 10: 012814422X
ISBN 13: 9780128144220
Language: EN, FR, DE, ES & NL

Dosage Form Design Parameters Book Review:

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Medicinal Chemistry with Pharmaceutical Product Development

Medicinal Chemistry with Pharmaceutical Product Development
Author: Debarshi Kar Mahapatra,Sanjay Kumar Bharti
Publsiher: CRC Press
Total Pages: 368
Release: 2019-02-04
ISBN 10: 0429947143
ISBN 13: 9780429947148
Language: EN, FR, DE, ES & NL

Medicinal Chemistry with Pharmaceutical Product Development Book Review:

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 Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research
Author: Anonim
Publsiher: Academic Press
Total Pages: 976
Release: 2020-09-02
ISBN 10: 0128144556
ISBN 13: 9780128144558
Language: EN, FR, DE, ES & NL

The Future of Pharmaceutical Product Development and Research Book Review:

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

Dosage Form Design Considerations

Dosage Form Design Considerations
Author: Anonim
Publsiher: Academic Press
Total Pages: 820
Release: 2018-07-28
ISBN 10: 0128144246
ISBN 13: 9780128144244
Language: EN, FR, DE, ES & NL

Dosage Form Design Considerations Book Review:

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Inhaled Pharmaceutical Product Development Perspectives

Inhaled Pharmaceutical Product Development Perspectives
Author: Anthony J. Hickey
Publsiher: Elsevier
Total Pages: 110
Release: 2017-11-23
ISBN 10: 0128123362
ISBN 13: 9780128123362
Language: EN, FR, DE, ES & NL

Inhaled Pharmaceutical Product Development Perspectives Book Review:

Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product. The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future. Discusses development strategies and best practices in the context of regulatory requirements Written by a broadly qualified expert drawing on the knowledge and critical opinions of key individuals in the field Includes a foreword by Charles G. Thiel

Benefit Risk Assessment in Pharmaceutical Research and Development

Benefit Risk Assessment in Pharmaceutical Research and Development
Author: Andreas Sashegyi,James Felli,Rebecca Noel
Publsiher: CRC Press
Total Pages: 220
Release: 2013-11-27
ISBN 10: 143986795X
ISBN 13: 9781439867952
Language: EN, FR, DE, ES & NL

Benefit Risk Assessment in Pharmaceutical Research and Development Book Review:

Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment. The book first presents interpretations of benefit and risk in the context of a molecule moving from preclinical evaluation into its early testing in humans. It next considers benefit and risk characterization and assessment during a molecule’s journey from its clinical evaluation in humans through its submission to regulators for marketing approval. Throughout these sections, the book offers insight into the role of benefit-risk assessment in heightening understanding among key stakeholders by shaping questions and guiding discussions among scientists, physicians, developers, and regulatory agencies. The book also focuses on a molecule’s entry into the marketplace as a drug available for consumption by people. It explores the role of benefit-risk assessment as the relevance of carefully collected clinical efficacy and safety metrics fades in the wake of real-world use and evidence of effectiveness and safety. Bringing together the expertise of 15 contributors from academia and the industry, this book offers an easy-to-read guide to the various facets of benefit-risk assessment in the major stages of pharmaceutical R&D. Suitable for those in both technical and managerial roles, it enables readers to communicate more effectively across their development chain as well as rationally and thoughtfully embed benefit-risk assessment into their R&D processes.

Basic Fundamentals of Drug Delivery

Basic Fundamentals of Drug Delivery
Author: Anonim
Publsiher: Academic Press
Total Pages: 810
Release: 2018-11-30
ISBN 10: 0128179104
ISBN 13: 9780128179109
Language: EN, FR, DE, ES & NL

Basic Fundamentals of Drug Delivery Book Review:

Basic Fundamentals of Drug Delivery covers the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable drug delivery system. The book also covers various approaches involved in optimizing the therapeutic performance of a biomolecule while designing its appropriate advanced formulation. Provides up-to-date information on translating the physicochemical properties of drugs into drug delivery systems Explores how drugs are administered via various routes, such as orally, parenterally, transdermally or through inhalation Contains extensive references and further reading for course and self-study

How to Integrate Quality by Efficient Design QbED in Product Development

How to Integrate Quality by Efficient Design  QbED  in Product Development
Author: Bhavishya Mittal
Publsiher: Academic Press
Total Pages: 274
Release: 2019-08-24
ISBN 10: 0128173041
ISBN 13: 9780128173046
Language: EN, FR, DE, ES & NL

How to Integrate Quality by Efficient Design QbED in Product Development Book Review:

The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development Discusses relevant literature references in quality risk management, business strategy, QbD, and product development Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand

Pharmaceutical Process Development

Pharmaceutical Process Development
Author: John Blacker,Michael T Williams
Publsiher: Royal Society of Chemistry
Total Pages: 374
Release: 2011-08-17
ISBN 10: 1849733074
ISBN 13: 9781849733076
Language: EN, FR, DE, ES & NL

Pharmaceutical Process Development Book Review:

Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology
Author: Institute of Medicine,Committee on Technological Innovation in Medicine
Publsiher: National Academies Press
Total Pages: 224
Release: 1991-02-01
ISBN 10: 030904491X
ISBN 13: 9780309044912
Language: EN, FR, DE, ES & NL

The Changing Economics of Medical Technology Book Review:

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 policies--as well as the involvement of numerous government agencies--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

Pharmaceutical Quality by Design
Author: Sarwar Beg,Md Saquib Hasnain
Publsiher: Academic Press
Total Pages: 448
Release: 2019-03-27
ISBN 10: 0128163720
ISBN 13: 9780128163726
Language: EN, FR, DE, ES & NL

Pharmaceutical Quality by Design Book Review:

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

Neuroscience Trials of the Future

Neuroscience Trials of the Future
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publsiher: National Academies Press
Total Pages: 110
Release: 2016-12-07
ISBN 10: 0309442559
ISBN 13: 9780309442558
Language: EN, FR, DE, ES & NL

Neuroscience Trials of the Future Book Review:

On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
Author: Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publsiher: John Wiley & Sons
Total Pages: 416
Release: 2017-09-01
ISBN 10: 1119356172
ISBN 13: 9781119356172
Language: EN, FR, DE, ES & NL

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Book Review:

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.

Innovation and Marketing in the Pharmaceutical Industry

Innovation and Marketing in the Pharmaceutical Industry
Author: Min Ding,Jehoshua Eliashberg,Stefan Stremersch
Publsiher: Springer Science & Business Media
Total Pages: 768
Release: 2013-10-31
ISBN 10: 1461478014
ISBN 13: 9781461478010
Language: EN, FR, DE, ES & NL

Innovation and Marketing in the Pharmaceutical Industry Book Review:

The pharmaceutical industry is one of today’s most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success—or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: · An extensive literature review, including coverage of research from fields other than marketing · an overview of how practitioners have addressed the topic · introduction of relevant analytical tools, such as statistics and ethnographic studies · suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.

Contraceptive Research and Development

Contraceptive Research and Development
Author: Institute of Medicine,Committee on Contraceptive Research and Development
Publsiher: National Academies Press
Total Pages: 536
Release: 1996-11-04
ISBN 10: 9780309175654
ISBN 13: 0309175658
Language: EN, FR, DE, ES & NL

Contraceptive Research and Development Book Review:

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.

Biopharmaceutics and Pharmacokinetics Considerations

Biopharmaceutics and Pharmacokinetics Considerations
Author: Anonim
Publsiher: Academic Press
Total Pages: 575
Release: 2021-07-15
ISBN 10: 9780128144251
ISBN 13: 0128144254
Language: EN, FR, DE, ES & NL

Biopharmaceutics and Pharmacokinetics Considerations Book Review:

Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce. Examines the most recent developments in biopharmaceutics and pharmacokinetics for pharmaceutical sciences Covers the principles, methodologies and technologies of biopharmaceutics and pharmacokinetics Focuses on the pharmaceutical sciences, but also encompasses aspects of toxicology, neuroscience, environmental sciences and nanotechnology

Biological Drug Products

Biological Drug Products
Author: Wei Wang,Manmohan Singh
Publsiher: John Wiley & Sons
Total Pages: 744
Release: 2013-08-29
ISBN 10: 1118695224
ISBN 13: 9781118695227
Language: EN, FR, DE, ES & NL

Biological Drug Products Book Review:

Tested and proven solutions to the challenges of biologicaldrug product development Biological drug products play a central role in combating humandiseases; however, developing new successful biological drugspresents many challenges, including labor intensive productionprocesses, tighter regulatory controls, and increased marketcompetition. This book reviews the current state of the science,offering readers a single resource that sets forth the fundamentalsas well as tested and proven development strategies for biologicaldrugs. Moreover, the book prepares readers for the challenges thattypically arise during drug development, offering straightforwardsolutions to improve their ability to pass through all theregulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with generalconsiderations for the development of any biological drug productand then explores the strategies and challenges involved in thedevelopment of specific types of biologics. Divided into fiveparts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts inbiological drug development. Contributions are based on acomprehensive review and analysis of the current literature as wellas the authors' first-hand experience developing and testing newdrugs. References at the end of each chapter serve as a gateway tooriginal research papers and reviews in the field. By incorporating lessons learned and future directions forresearch, Biological Drug Products enables pharmaceuticalscientists and students to improve their success rate in developingnew biologics to treat a broad range of human diseases.