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| pharmaceutical biotechnology: Pharmaceutical Biotechnology Daan J. A. Crommelin, Robert D. Sindelar, 2002-11-14 The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well. |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Gary Walsh, 2013-04-25 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 |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Oliver Kayser, Heribert Warzecha, 2012-03-27 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. |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Daan J. A. Crommelin, Robert D. Sindelar, Bernd Meibohm, 2013-10-22 This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fourth Edition will completely update the previous edition, and will also include additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech. |
| pharmaceutical biotechnology: Handbook of Pharmaceutical Biotechnology Jay P Rho, Stan G Louie, 2003-04-02 This compendium of drugs produced by biotechnology covers general principles of biotechnology and pharmaceuticals. Descriptions of each type of drug break down each product by pharmacology, toxicities, pharmacokinetics, clinical applications, and dosage guides. There are also reviews of prescription. |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Deepshikha P. Katare, Altaf Ahmad, Vidhu Aeri, 2009 Pharmaceutical biotechnology is evolving as an increasingly vital tool in the field of life sciences by contributing to diagnostic medical tests, therapeutic drugs and also gene therapy for hereditary diseases. Pharmaceutical biotechnology tools such as recombinant proteins and transgenic organisms have revolutionised life sciences. This book aims to explain the basics and applications of pharmaceutical biotechnology to readers new to the subject. It is written and presented in a clear, easy-to-follow manner, and contains numerous figures and illustrations to explain the material. Consisting of 25 chapters divided into 5 units:- genetic engineering, plant biotechnology, animal biotechnology, microbiology and industrial biotechonology and nanobiotechnology – the book gives concise descriptions across all areas of biotechnology, brings the reader up to date with the latest findings, and also looks at what the future prospects have in store. Each chapter also offers suggested readings for further study. The three young authors have provided an excellent overview to the field of pharmaceutical biotechnology. The book can be read both as an introduction to the subject, and a synopsis of past, present and future findings. For this reason, it will be a valuable addition in any life science library. |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Daan J. A. Crommelin, Robert D. Sindelar, 2004-06-01 The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well. |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology S. P. Vyas, V. Dixit, 2018-05-30 Covers all important biotechnological topics of academic and industrial interests. Subjects such as immobilization recombinant DNA technology, monoclonal antibodies, protein and peptide delivery, gene delivery, molecular principles of drug targeting, and new generation vaccines, are all covered in detail. The book covers basic topics for both undergraduates and postgraduates, and effectively provides quality concepts and potential problems in research in biotechnology and newer drug delivery systems. |
| pharmaceutical biotechnology: Introduction to Pharmaceutical Biotechnology, Volume 1 (Second Edition): Basic Techniques and Concepts , 2024-11 |
| pharmaceutical biotechnology: Current Applications of Pharmaceutical Biotechnology Ana Catarina Silva, João Nuno Moreira, José Manuel Sousa Lobo, Hugo Almeida, 2020-02-06 This book offers an authoritative review of biopharmaceuticals and their clinical relevance. Biopharmaceuticals have been showing high therapeutic potential by means of biological and biosimilar medicines, particularly for the treatment of cancer, chronic diseases (e.g. diabetes, Crohn's disease, psoriasis and rheumatoid arthritis), neurodegenerative disorders (e.g. multiple sclerosis), and they have also been contributing to the progress of innovative therapies such as assisted reproductive medicine. Since the eighties, several biopharmaceuticals have been approved and, due to patents expiration, many biosimilars are also marketed. In this book, readers will find the most relevant updated information about the main clinical applications of pharmaceutical biotechnology. The authors provide expert analysis about the industrial challenges of recombinant proteins and the different classes of biopharmaceuticals, including monoclonal antibodies, vaccines, growth factors and stem cells. Topics such as bioprinting technologies in tissue engineering, gene therapy and personalized medicine are also covered in this book. Professionals, students and researchers interested in this field will find this work an important account. |
| pharmaceutical biotechnology: Advances in Pharmaceutical Biotechnology Jayanta Kumar Patra, Amritesh C. Shukla, Gitishree Das, 2021-03-31 This book explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical uses. The foundations of pharmaceutical biotechnology lie mainly in the capability of plants, microorganism, and animals to produce low and high molecular weight compounds useful as therapeutics. Pharmaceutical biotechnology has flourished since the advent of recombinant DNA technology and metabolic engineering, supported by the well-developed bioprocess technology. A large number of monoclonal antibodies and therapeutic proteins have been approved, delivering meaningful contributions to patients’ lives, and the techniques of biotechnology are also a driving force in modern drug discovery. Due to this rapid growth in the importance of biopharmaceuticals and the techniques of biotechnologies to modern medicine and the life sciences, the field of pharmaceutical biotechnology has become an increasingly important component in the education of pharmacists and pharmaceutical scientists. This book will serve as a complete one-stop source on the subject for undergraduate and graduate pharmacists, pharmaceutical science students, and pharmaceutical scientists in industry and academia. |
| pharmaceutical biotechnology: Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries Pete Harpum, 2011-09-20 This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years. |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Gary Walsh, 2007-08-13 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 |
| pharmaceutical biotechnology: Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems Ashok Katdare, Mahesh Chaubal, 2006-07-28 To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics. |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Adalberto Pessoa, Michele Vitolo, Paul Frederick Long, 2021-07-15 Pharmaceutical Biotechnology: A Focus on Industrial Application covers the development of new biopharmaceuticals as well as the improvement of those being produced. The main purpose is to provide background and concepts related to pharmaceutical biotechnology, together with an industrial perspective. This is a comprehensive text for undergraduates, graduates and academics in biochemistry, pharmacology and biopharmaceutics, as well as professionals working on the interdisciplinary field of pharmaceutical biotechnology. Written with educators in mind, this book provides teachers with background material to enhance their classes and offers students and other readers an easy-to-read text that examines the step-by-step stages of the development of new biopharmaceuticals. Features: Discusses specific points of great current relevance in relation to new processes as well as traditional processes Addresses the main unitary operations used in the biopharmaceutical industry such as upstream and downstream Includes chapters that allow a broad evaluation of the production process Dr. Adalberto Pessoa Jr. is Full Professor at the School of Pharmaceutical Sciences of the University of São Paulo and Visiting Senior Professor at King’s College London. He has experience in enzyme and fermentation technology and in the purification processes of biotechnological products such as liquid–liquid extraction, cross-flow filtration and chromatography of interest to the pharmaceutical and food industries. Dr. Michele Vitolo is Full Professor at the School of Pharmaceutical Sciences of the University of São Paulo. He has experience in enzyme technology, in immobilization techniques (aiming the reuse of the biocatalyst) and in the operation of membrane reactors for obtaining biotechnological products of interest to the pharmaceutical, chemical and food industries. Dr. Paul F. Long is Professor of Biotechnology at King's College London and Visiting International Research Professor at the University of São Paulo. He is a microbiologist by training and his research uses a combination of bioinformatics, laboratory and field studies to discover new medicines from nature, particularly from the marine environment. |
| pharmaceutical biotechnology: Business Development for the Biotechnology and Pharmaceutical Industry Martin Austin, 2016-04-08 Business Development in the biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development and marketing, locally or across the globe. Asset sales, mergers and corporate takeovers are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of products from the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects. The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world. |
| pharmaceutical biotechnology: Biocatalysis in the Pharmaceutical and Biotechnology Industries Ramesh N. Patel, 2006-09-26 Because enzyme-catalyzed reactions exhibit higher enantioselectivity, regioselectivity, substrate specificity, and stability, they require mild conditions to react while prompting higher reaction efficiency and product yields. Biocatalysis in the Pharmaceutical and Biotechnology Industries examines the use of catalysts to produce fine chemic |
| pharmaceutical biotechnology: Modern Applications of Plant Biotechnology in Pharmaceutical Sciences Saurabh Bhatia, Kiran Sharma, Randhir Dahiya, Tanmoy Bera, 2015-07-22 Modern Applications of Plant Biotechnology in Pharmaceutical Sciences explores advanced techniques in plant biotechnology, their applications to pharmaceutical sciences, and how these methods can lead to more effective, safe, and affordable drugs. The book covers modern approaches in a practical, step-by-step manner, and includes illustrations, examples, and case studies to enhance understanding. Key topics include plant-made pharmaceuticals, classical and non-classical techniques for secondary metabolite production in plant cell culture and their relevance to pharmaceutical science, edible vaccines, novel delivery systems for plant-based products, international industry regulatory guidelines, and more. Readers will find the book to be a comprehensive and valuable resource for the study of modern plant biotechnology approaches and their pharmaceutical applications. - Builds upon the basic concepts of cell and plant tissue culture and recombinant DNA technology to better illustrate the modern and potential applications of plant biotechnology to the pharmaceutical sciences - Provides detailed yet practical coverage of complex techniques, such as micropropogation, gene transfer, and biosynthesis - Examines critical issues of international importance and offers real-life examples and potential solutions |
| pharmaceutical biotechnology: INDUSTRIAL PHARMACEUTICAL BIOTECHNOLOGY. HEINRICH. KLEFENZ, 2021 |
| pharmaceutical biotechnology: Handbook of Pharmaceutical Biotechnology Shayne Cox Gad, 2007-05-23 A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and validation methods Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry. |
| pharmaceutical biotechnology: Introduction to Pharmaceutical Biotechnology, Volume 2 (Second Edition) SAURABH. BHATIA, 2024-07-27 |
| pharmaceutical biotechnology: Biotechnology and Pharmacy J.M. Pezzuto, M.E. Johnson, H.R. Manasse, 2013-03-09 Biotechnology and Pharmacy offers a unique overview of the principles of biotechnology and their applications in the pharmaceutical sciences. The book assumes a basic knowledge of biology and chemistry and was written as a text suitable for students of pharmacy or other health sciences. The first part of the book describes the basic elements of biotechnology, such as recombinant DNA and monoclonal antibody technology; the second part comprehensively covers applications of biotechnology in the diagnosis and treatment of disease; and the final part offers a practical discussion of how biotechnology products will affect the practice of pharmacy. Microbiologists, biochemists, and medicinal chemists will also find this book to be a valuable reference. |
| pharmaceutical biotechnology: Biotechnology and Pharmaceutical Interview Guide (Color) RxCommercial Research International Inc., 2012-11-30 |
| pharmaceutical biotechnology: Cell Culture Technology for Pharmaceutical and Cell-Based Therapies Sadettin Ozturk, Wei-Shou Hu, 2005-08-30 Edited by two of the most distinguished pioneers in genetic manipulation and bioprocess technology, this bestselling reference presents a comprehensive overview of current cell culture technology used in the pharmaceutical industry. Contributions from several leading researchers showcase the importance of gene discovery and genomic technology devel |
| pharmaceutical biotechnology: Development and Manufacture of Protein Pharmaceuticals Steve L. Nail, Michael J. Akers, 2012-12-06 In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality. |
| pharmaceutical biotechnology: Textbook of Pharmaceutical Biotechnology Chandrakant Kokate, Pramod H.J, SS Jalalpure, 2012-05-14 Textbook of Pharmaceutical Biotechnology |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology K. Sambamurthy, 2006 The Textbook On Pharmaceutical Biotechnology Provides Comprehensively The Fundamental Concepts And Principles In Biotechnology To Expatiate And Substantiate Its Numerous Modern Applications With Regard To The Spectacular Development In The Pharmaceutical Industry. In A Broader Perspective, The Students Studying Biotechnology At Undergraduate And Postgraduate Levels Shall Be Grossly Benefited By Its Well-Planned Systematically Developed, Structured, Illustrated, Expanded, Elaborated, And Profusely Exemplified Subject Matter.It Essentially Comprise Five Major Chapters, Namely: Immunology And Immunological Preparations; Genetic Recombination; Antibiotics; Microbial Transformations; And Enzyme Immobilization. Besides, There Are Five Auxiliary Chapters, Namely, Advent Of Biotechnology; Biosensor Technology; Bioinformatics And Data Mining; Regulatory Issues In Biotechnology; And Safety In Biotechnology, Which Have Been Specifically Included So As To Stimulate The Students, Interest And Broaden Their Horizon Of Knowledge And Wisdom.The Authors Earnestly Believe That The Wide Coverage Of Various Topics Mentioned Above Would Certainly Render Pharmaceutical Biotechnology To Serve As An Exclusive Source Of Information S, Ideas, Inspirations Towards Research, And Finding Newer Possible Practical Solutions To Problems Encountered In The Ever Green Pasture Using Knowledge Of Biotechnology In The Pharmaceutical Industry. |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Carlos A. Guzmán, Giora Z. Feuerstein, 2010-01-01 Pharmaceutical Biotechnology is a unique compilation of reviews addressing frontiers in biologicals as a rich source for innovative medicines. This book fulfills the needs of a broad community of scientists interested in biologicals from diverse perspectives—basic research, biotechnology, protein engineering, protein delivery, medicines, pharmaceuticals and vaccinology. The diverse topics range from advanced biotechnologies aimed to introduce novel, potent engineered vaccines of unprecedented efficacy and safety for a wide scope of human diseases to natural products, small peptides and polypeptides engineered for discrete prophylaxis and therapeutic purposes. Modern biologicals promise to dramatically expand the scope of preventive medicine beyond the infectious disease arena into broad applications in immune and cancer treatment, as exemplified by anti-EGFR receptors antibodies for the treatment of breast cancer. The exponential growth in biologicals such as engineered proteins andvaccines has been boosted by unprecedented scientific breakthroughs made in the past decades culminating in an in-depth fundamental understanding of the scientific underpinnings of immune mechanisms together with knowledge of protein and peptide scaffolds that can be deliberately manipulated. This has in turn led to new strategies and processes. Deciphering the human, mammalian and numerous pathogens’ genomes provides opportunities that never before have been available—identification of discrete antigens (genomes and antigenomes) that lend themselves to considerably improved antigens and monoclonal antibodies, which with more sophisticated engineered adjuvants and agonists of pattern recognition receptors present in immune cells, deliver unprecedented safety and efficacy. Technological development such a nanobiotechnologies (dendrimers, nanobodies and fullerenes), biological particles (viral-like particles and bacterial ghosts) and innovative vectors (replication-competent attenuated,replication-incompetent recombinant and defective helper-dependent vectors) fulfill a broad range of cutting-edge research, drug discovery and delivery applications. Most recent examples of breakthrough biologicals include the human papilloma virus vaccine (HPV, prevention of women genital cancer) and the multivalent Pneumoccocal vaccines, which has virtually eradicated in some populations a most prevalent bacterial ear infection (i.e., otitis media). It is expected that in the years to come similar success will be obtained in the development of vaccines for diseases which still represent major threats for human health, such as AIDS, as well as for the generation of improved vaccines against diseases like pandemic flu for which vaccines are currently available. Furthermore, advances in comparative immunology and innate immunity revealed opportunities for innovative strategies for ever smaller biologicals and vaccines derived from species such as llama and sharks, which carry tremendous potential for innovative biologicals already in development stages in many pharmaceutical companies. Such recent discoveries and knowledge exploitations hold the promise for breakthrough biologicals, with the coming decade. Finally, this book caters to individuals not directly engaged in the pharmaceutical drug discovery process via a chapter outlining discovery, preclinical development, clinical development and translational medicine issues that are critical the drug development process. The authors and editors hope that this compilation of reviews will help readers rapidly and completely update knowledge and understanding of the frontiers in pharmaceutical biotechnologies. |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Oliver Kayser, Rainer H. Müller, 2006-03-06 With its focus on industrial pharmaceutical research, written by international experts from the industry, this book fills in a gap in the existing literature. It reflects the combination of such pharmaceutical interests as drug delivery, drug targeting, quality and safety management, drug approval and regulation, patenting issues and biotechnology fundamentals. Thus it provides practitioners in pharmaceutical biotechnology with all the relevant information from the shelf. The first part offers a comprehensive survey and review of the rapidly increasing array of biopharmaceuticals derived from the molecular biological approaches now widely available. This is followed by an extra section devoted to the very critical patenting and drug regulation issues. The whole is rounded off by detailed monographs of biotechnologically developed drugs that are already on the market. With a foreword of by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at the Massachusetts Institute of Technology. In 2002, he received the Charles Stark Draper Prize, the highest recognition for an engineer. Professor Langer is member of all three national academies - the Institute of Medicine, the National Academy of Engineering, and the National Academy of Sciences: The book attempts to provide a balanced view of the biotechnological industry and the number of experts from industry sharing their knowledge and experience with the audience gives the book an outstanding value. All contributors provide with each chapter an up-to-date review on key topics in pharmaceutical biotechnology. This work is not only a valuable tool for the industrial expert but also for all pharmacists and scientists from related areas who wish to work with biotech drugs. |
| pharmaceutical biotechnology: Nonclinical Statistics for Pharmaceutical and Biotechnology Industries Lanju Zhang, 2016-01-13 This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions. |
| pharmaceutical biotechnology: Economic Regulation and Its Reform Nancy L. Rose, 2014-08-29 The past thirty years have witnessed a transformation of government economic intervention in broad segments of industry throughout the world. Many industries historically subject to economic price and entry controls have been largely deregulated, including natural gas, trucking, airlines, and commercial banking. However, recent concerns about market power in restructured electricity markets, airline industry instability amid chronic financial stress, and the challenges created by the repeal of the Glass-Steagall Act, which allowed commercial banks to participate in investment banking, have led to calls for renewed market intervention. Economic Regulation and Its Reform collects research by a group of distinguished scholars who explore these and other issues surrounding government economic intervention. Determining the consequences of such intervention requires a careful assessment of the costs and benefits of imperfect regulation. Moreover, government interventions may take a variety of forms, from relatively nonintrusive performance-based regulations to more aggressive antitrust and competition policies and barriers to entry. This volume introduces the key issues surrounding economic regulation, provides an assessment of the economic effects of regulatory reforms over the past three decades, and examines how these insights bear on some of today’s most significant concerns in regulatory policy. |
| pharmaceutical biotechnology: Patents for Chemicals, Pharmaceuticals and Biotechnology Philip W. Grubb, 2004 Previous editions, 1st and 2nd, published under titles : 1st (1982) Patents for chemists ; 2nd (1986) Patents in chemistry and biotechnology ; 3rd edition published in 1999. |
| pharmaceutical biotechnology: The Billion-Dollar Molecule Barry Werth, 1995-03 This inside account of Vertex, a start-up pharmaceutical company, conveys the exciting drama being played out in the pioneering and enormously profitable field of drug research. Vertex is dedicated to designing--atom by atom--a new life-saving immunosuppressant drug that has major implications for HIV research. |
| pharmaceutical biotechnology: Innovation in Pharmaceutical Biotechnology Comparing National Innovation Systems at the Sectoral Level OECD, 2006-03-29 This publication examines the innovation system in pharmaceutical biotechnology in eight OECD countries - Belgium, Finland, France, Germany, Japan, the Netherlands, Norway and Spain - and makes recommendations advocating an integrated policy approach. |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Sreenivasulu V./ Jayaveera K.N. & Adinarayana K., In this book the theory is explained in simplest way and finding the numerical solutions for several methods has been treated in detail and illustrated by large number of numerical examples and questions from universities papers. |
| pharmaceutical biotechnology: PHARMACEUTICAL BIOTECHNOLOGY Prof.(Dr.) N.G.RAGHAVENDRA RAO, Dr. J. Naveena Lavanya Latha, Mrs. Swati Vikram Patil, Dr. L. MATSYAGIRI, Pharmaceutical Biotechnology provides an in-depth introduction to the dynamic field of biopharmaceuticals for students majoring in Pharmacy and associated Medical and Pharmaceutical disciplines. The first chapters provide a foundational introduction to protein science and recombinant DNA technology, with an emphasis on the medicinal application of these fields. Construction, manufacture, and examination of these chemicals are the subjects of subsequent chapters. When it comes to current techniques in pharmaceutical biotechnology, this book is invaluable to pharmaceutical scientists, doctors, and academic researchers. The clear and unbiased organization of this book's material will also be useful to corporate researchers. Pharmaceutical biotechnology is a relatively new and growing field in which the principles of biotechnology are applied to the development of drugs. The book's intended audience is pharmacy students, but it will also be of interest to anyone studying biotechnology and medicine. The book's goal is to introduce students to the fundamentals of biotechnology in great depth. |
| pharmaceutical biotechnology: Membrane Processes in Biotechnology and Pharmaceutics Catherine Charcosset, 2012-01-25 Membrane processes are increasingly used in pharmaceutical and biochemical engineering and biotechnology for concentration and purification, synthesis of molecules and drug delivery systems, and support for biochemical reactions. This book provides a state-of-the art overview of the classical membrane processes used in pharmaceutical and biochemical engineering and biotechnology, such as ultrafiltration, microfiltration, virus filtration, membrane chromatography, membrane emulsification, liquid membranes and membrane bioreactors. It describes the general rules (principles, choice of configurations, membranes, parameters, etc.), recent developments (fouling control, increase permeate flux and selectivity, etc.), applications, and theoretical descriptions. Further, it presents emerging processes such as solvent resistant nanofiltration and membrane crystallization. - Presents classical membrane processes such as ultrafiltration, microfiltration, virus filtration, membrane chromatography, membrane emulsification, liquid membranes and membrane bioreactors - Presents emerging processes such as solvent resistant nanofiltration and membrane crystallization - Gives a complete description of each technique (principles, membrane materials and devices, fouling control, and theoretical description) - Contains numerous examples of applications - Includes a uniform notation throughout the book enhancing the presentation and understanding of the content - Includes extensive list of references |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology Dr. S. Jayaraman, Dr. Richa Ohri, Dr. Pankaj Verma, 2021-03-11 Explore the budget-friendly e-Book version of ‘Pharmaceutical Biotechnology’ for B.Pharm 6th Semester, following the PCI Syllabus. Published by Thakur Publication, this digital edition delivers the same comprehensive content at just a fraction of the cost of the paperback. Don't miss out on this opportunity to save 60% compared to the physical edition. Grab your copy today and elevate your learning experience! |
| pharmaceutical biotechnology: Pharmaceutical Biotechnology in Drug Development Muhammad Sajid Hamid Akash, Kanwal Rehman, Kanwal Irshad, Shuqing Chen, 2023-04-21 Pharmaceutical Biotechnology in Drug Development summarizes key concepts and the latest developments of biotechnology applied to the development of biopharmaceuticals. Chapters present a comprehensive collection of introductory biotechnology technologies and their modern concepts and cover pharmacokinetic and pharmacodynamic behavior of biopharmaceuticals and modification techniques of amino acids and nucleic acid. Other sections focus on topics such as gene therapy, immunological preparations and nanoparticles which are the major contributions of pharmaceutical biotechnology. Final chapters discuss emerging techniques in the field of pharmaceutical biotechnology to meet current patient and health care demand. This book is an essential reference useful for pharmaceutical scientists, clinicians and academic researchers who want easy access to up-to-date practices of pharmaceutical biotechnology. Corporate researchers will also benefit from this book's succinct and objective content structure. - Includes key concepts at the foundation of the technology and relevant for protein therapeutics - Explains how advances in other areas such as genomics, proteomics and high-throughput screening have paved the way for exploring new avenues of drug discovery - Covers the importance of biotechnology in the development of new biopharmaceuticals, along with their pharmacodynamics and pharmacokinetics |
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