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Biopharmaceutics Applications In Drug Development
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Book Synopsis Biopharmaceutics Applications in Drug Development by : Rajesh Krishna
Download or read book Biopharmaceutics Applications in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2007-09-20 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.
Book Synopsis Biopharmaceutical Drug Design and Development by : Susanna Wu-Pong
Download or read book Biopharmaceutical Drug Design and Development written by Susanna Wu-Pong and published by Springer Science & Business Media. This book was released on 2010-01-11 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive examination of the newest biopharmaceutical drugs. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, and contains a review of the Human Genome Project.
Book Synopsis Biotechnology and Biopharmaceuticals by :
Download or read book Biotechnology and Biopharmaceuticals written by and published by John Wiley & Sons. This book was released on 2013-09-19 with total page 744 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.
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
Book Synopsis Biopharmaceutics Modeling and Simulations by : Kiyohiko Sugano
Download or read book Biopharmaceutics Modeling and Simulations written by Kiyohiko Sugano and published by John Wiley & Sons. This book was released on 2012-07-31 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive introduction to using modeling and simulation programs in drug discovery and development Biopharmaceutical modeling has become integral to the design and development of new drugs. Influencing key aspects of the development process, including drug substance design, formulation design, and toxicological exposure assessment, biopharmaceutical modeling is now seen as the linchpin to a drug's future success. And while there are a number of commercially available software programs for drug modeling, there has not been a single resource guiding pharmaceutical professionals to the actual tools and practices needed to design and test safe drugs. A guide to the basics of modeling and simulation programs, Biopharmaceutics Modeling and Simulations offers pharmaceutical scientists the keys to understanding how they work and are applied in creating drugs with desired medicinal properties. Beginning with a focus on the oral absorption of drugs, the book discusses: The central dogma of oral drug absorption (the interplay of dissolution, solubility, and permeability of a drug), which forms the basis of the biopharmaceutical classification system (BCS) The concept of drug concentration How to simulate key drug absorption processes The physiological and drug property data used for biopharmaceutical modeling Reliable practices for reporting results With over 200 figures and illustrations and a peerless examination of all the key aspects of drug research—including running and interpreting models, validation, and compound and formulation selection—this reference seamlessly brings together the proven practical approaches essential to developing the safe and effective medicines of tomorrow.
Book Synopsis Biopharmaceutics and Pharmacokinetics Considerations by :
Download or read book Biopharmaceutics and Pharmacokinetics Considerations written by and published by Academic Press. This book was released on 2021-07-07 with total page 754 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Quality by Design for Biopharmaceutical Drug Product Development by : Feroz Jameel
Download or read book Quality by Design for Biopharmaceutical Drug Product Development written by Feroz Jameel and published by Springer. This book was released on 2015-04-01 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Book Synopsis Biopharmaceutics by : Hannah Batchelor
Download or read book Biopharmaceutics written by Hannah Batchelor and published by John Wiley & Sons. This book was released on 2021-12-20 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore the latest research in biopharmaceutics from leading contributors in the field In Biopharmaceutics - From Fundamentals to Industrial Practice, distinguished Scientists from the UK's Academy of Pharmaceutical Sciences Biopharmaceutica Focus Group deliver a comprehensive examination of the tools used within the field of biopharmaceutics and their applications to drug development. This edited volume is an indispensable tool for anyone seeking to better understand the field of biopharmaceutics as it rapidly develops and evolves. Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow. Readers will find insightful discussions of physiologically based modeling as a valuable asset in the biopharmaceutics toolkit and how to apply the principles of the field to special populations. The book goes on to discuss: Thorough introductions to biopharmaceutics, basic pharmacokinetics, and biopharmaceutics measures Comprehensive explorations of solubility, permeability, and dissolution Practical discussions of the use of biopharmaceutics to inform candidate drug selection and optimization, as well as biopharmaceutics tools for rational formulation design In-depth examinations of biopharmaceutics classification systems and regulatory biopharmaceutics, as well as regulatory biopharmaceutics and the impact of anatomy and physiology Perfect for professionals working in the pharmaceutical and biopharmaceutical industries, Biopharmaceutics - From Fundamentals to Industrial Practice is an incisive and up-to-date resource on the practical, pharmaceutical applications of the field.
Book Synopsis Applications of Pharmacokinetic Principles in Drug Development by : Rajesh Krishna
Download or read book Applications of Pharmacokinetic Principles in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2004 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a collection of articles that representindividual and expert perspectives in both preclinical and clinicaldevelopment, including case studies on real-life examples ofsuccessful drugs that add value to the pharmacokinetic principleslearned and applied. Unlike existing books that focus onpharmacokinetic theory, the current book emphasizes application ofpharmacokinetic principles in new drug development.
Book Synopsis The Science and Business of Drug Discovery by : Edward D. Zanders
Download or read book The Science and Business of Drug Discovery written by Edward D. Zanders and published by Springer Nature. This book was released on 2020-11-09 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Science and Business of Drug Discovery is written for those who want to learn about the biopharmaceutical industry and its products whatever their level of technical knowledge. Its aim is to demystify the jargon used in drug development, but in a way that avoids over simplification and the resulting loss of key information. Each of the twenty chapters is illustrated with figures and tables which clarify some of the more technical points being made. Also included is a drug discovery case history which draws the relevant material together into a single chapter. In recognizing that it is difficult to navigate through the many external resources dealing with drug development, the book has been written to guide the reader towards the most appropriate information sources, including those listed in the two appendices. The following topics are covered: Different types of drugs: from small molecules to stem cells Background to chemistry of small and large molecules Historical background to drug discovery, pharmacology and biotechnology The drug discovery pipeline: from target discovery to marketed medicine Commercial aspects of drug discovery Challenges to the biopharmaceutical industry and its responses Material of specific interest to technology transfer executives, recruiters and pharmaceutical translators
Book Synopsis Introduction to Biopharmaceutics by : Milo Gibaldi
Download or read book Introduction to Biopharmaceutics written by Milo Gibaldi and published by . This book was released on 1971 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Pharmaceutical Biotechnology by : Oliver Kayser
Download or read book Pharmaceutical Biotechnology written by Oliver Kayser and published by John Wiley & Sons. This book was released on 2012-05-21 with total page 677 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Introduction to Biological and Small Molecule Drug Research and Development by : C. Robin Ganellin
Download or read book Introduction to Biological and Small Molecule Drug Research and Development written by C. Robin Ganellin and published by Academic Press. This book was released on 2013-05-07 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to Biological and Small Molecule Drug Research and Development provides, for the first time, an introduction to the science behind successful pharmaceutical research and development programs. The book explains basic principles, then compares and contrasts approaches to both biopharmaceuticals (proteins) and small molecule drugs, presenting an overview of the business and management issues of these approaches. The latter part of the book provides carefully selected real-life case studies illustrating how the theory presented in the first part of the book is actually put into practice. Studies include Herceptin/T-DM1, erythropoietin (Epogen/Eprex/NeoRecormon), anti-HIV protease inhibitor Darunavir, and more. Introduction to Biological and Small Molecule Drug Research and Development is intended for late-stage undergraduates or postgraduates studying chemistry (at the biology interface), biochemistry, medicine, pharmacy, medicine, or allied subjects. The book is also useful in a wide variety of science degree courses, in post-graduate taught material (Masters and PhD), and as basic background reading for scientists in the pharmaceutical industry. For the first time, the fundamental scientific principles of biopharmaceuticals and small molecule chemotherapeutics are discussed side-by-side at a basic level Edited by three senior scientists with over 100 years of experience in drug research who have compiled the best scientific comparison of small molecule and biopharmaceuticals approaches to new drugs Illustrated with key examples of important drugs that exemplify the basic principles of pharmaceutical drug research and development
Book Synopsis Drug and Biological Development by : Ronald P. Evens
Download or read book Drug and Biological Development written by Ronald P. Evens and published by Springer Science & Business Media. This book was released on 2007-08-14 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.
Book Synopsis Developing Solid Oral Dosage Forms by : Yihong Qiu
Download or read book Developing Solid Oral Dosage Forms written by Yihong Qiu and published by Academic Press. This book was released on 2009-03-10 with total page 978 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies
Book Synopsis Biopharmaceuticals by : Ming-Kung Yeh
Download or read book Biopharmaceuticals written by Ming-Kung Yeh and published by BoD – Books on Demand. This book was released on 2018-09-19 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals are derived from biological sources, either live organisms or their active components; nowadays, they are mainly produced by biotechnologies. Biopharmaceuticals are extensively used in the treatment of various diseases such as cardiovascular, metabolic, neurological diseases, cancer, and others for which there are no available therapeutic methods. With the advance of science, biopharmaceuticals have revolutionized the treatment, prevention, and diagnosis of many patients with disabling and life-threatening diseases. Innovative biopharmaceuticals definitely improve the life quality of patients and enhance the effectiveness of the healthcare system. This book encompasses the discovery, production, application, and regulation of biopharmaceuticals to demonstrate their research achievement, prospects, and challenges. We expect the significance of biopharmaceuticals to be revealed and emphasized by this book.
Book Synopsis Applied Biopharmaceutics and Pharmacokinetics by : Leon Shargel
Download or read book Applied Biopharmaceutics and Pharmacokinetics written by Leon Shargel and published by McGraw-Hill/Appleton & Lange. This book was released on 1993 with total page 625 pages. Available in PDF, EPUB and Kindle. Book excerpt:
