Handbook of Pharmaceutical Biotechnology

Handbook of Pharmaceutical Biotechnology PDF

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2007-05-23

Total Pages: 1681

ISBN-13: 0470117109

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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.

Handbook of Pharmaceutical Biotechnology

Handbook of Pharmaceutical Biotechnology PDF

Author: Jay P Rho

Publisher: CRC Press

Published: 2003-03-31

Total Pages: 214

ISBN-13: 9780789016355

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Stay up to date with changes in the biopharmaceutical products market! With the growth rate of biopharmaceutical products ascending rapidly since the 1980s, the number of biotechnology companies has risen to more than 1200 new businesses in the Unites States alone. This dramatic increase creates a new set of challenges in education, putting demands on teachers and students to keep pace with innovations in terminology and techniques. The Handbook of Pharmaceutical Biotechnology is essential in meeting those challenges. A practical compendium of biotechnology-produced drugs, the Handbook of Pharmaceutical Biotechnology covers general principles of biotechnology and pharmaceuticals, putting usable information in the hands of those who need it most. The book presents descriptions that break down each pharmaceutical product by pharmacology, pharmacokinetics, clinical applications, toxicities, and dosage guidelines. It also reviews prescription products, discussing clinical uses and trials, adverse reactions, and more. Tables, figures, and extensive references add to each comprehensive summary. The Handbook of Pharmaceutical Biotechnology also includes up-to-date information on: monoclonal antibodies (Abciximab, Muromonab-CD3) enzymes and regulators of enzyme activity (Alteplase, clotting factors, Dornase alpha) anticytokines olgonucleotide and gene therapy hematopoietic growth factors (interleukins, interferons, colony stimulating factors, erythropoietin) As the worldwide production and sales of biotechnology-derived pharmaceuticals and diagnostics continues to grow, teachers, students, and clinical pharmacists need to maintain a clear and current understanding of the field. The Handbook of Pharmaceutical Biotechnology presents a thoughtful and thorough guide to keeping pace in this evolving industry.

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook PDF

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2008-03-21

Total Pages: 1384

ISBN-13: 0470259809

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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

The Oxford Handbook of the Economics of the Biopharmaceutical Industry

The Oxford Handbook of the Economics of the Biopharmaceutical Industry PDF

Author: Patricia M. Danzon

Publisher: Oxford University Press

Published: 2012-04-12

Total Pages: 624

ISBN-13: 0199909261

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The biopharmaceutical industry has been a major driver of technological change in health care, producing unprecedented benefits for patients, cost challenges for payers, and profits for shareholders. As consumers and companies benefit from access to new drugs, policymakers around the globe seek mechanisms to control prices and expenditures commensurate with value. More recently the 1990s productivity boom of new products has turned into a productivity bust, with fewer and more modest innovations, and flat or declining revenues for innovative firms as generics replace their former blockbuster products. This timely volume examines the economics of the biopharmaceutical industry, with eighteen chapters by leading academic health economists. Part one examines the economics of biopharmaceutical innovation including determinants of the costs and returns to new drug development; how capital markets finance R&D and how costs of financing the biopharmaceutical industry compare to financing costs for other industries; the effects of safety and efficacy regulation by the Food and Drug Administration (FDA) and of price and reimbursement regulation on incentives for innovation; and the role of patents and regulatory exclusivities. Part two examines the market for biopharmaceuticals with chapters on prices and reimbursement in the US, the EU, and other industrialized countries, and in developing countries. It looks at the optimal design of insurance for drugs and the effects of cost sharing on spending and on health outcomes; how to measure the value of pharmaceuticals using pharmacoeconomics, including theory, practical challenges, and policy issues; how to measure pharmaceutical price growth over time and recent evidence; empirical evidence on the value of pharmaceuticals in terms of health outcomes; promotion of pharmaceuticals to physicians and consumers; the economics of vaccines; and a review of the evidence on effects of mergers, acquisitions and alliances. Each chapter summarizes the latest insights from theory and recent empirical evidence, and outlines important unanswered questions and areas for future research. Based on solid economics, it is nevertheless written in terms accessible to the general reader. The book is thus recommended reading for academic economists and non-economists, and for those in industry and policy who wish to understand the economics of this fascinating industry.

Cleaning Validation Manual

Cleaning Validation Manual PDF

Author: Syed Imtiaz Haider

Publisher: CRC Press

Published: 2010-05-24

Total Pages: 608

ISBN-13: 1439826617

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During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-

A Biotech Manager's Handbook

A Biotech Manager's Handbook PDF

Author: M O'Neill

Publisher: Elsevier

Published: 2012-05-02

Total Pages: 414

ISBN-13: 1908818158

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A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. No other 'how to' manual exists for this sector Written by a range of expert professionals in each area, all in one book Is the only 'bench to bedside' book covering the whole spectrum of development

Pharmaceutical Biotechnology

Pharmaceutical Biotechnology PDF

Author: Oliver Kayser

Publisher: John Wiley & Sons

Published: 2012-05-21

Total Pages: 677

ISBN-13: 3527329943

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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 PDF

Author: Daan J. A. Crommelin

Publisher: CRC Press

Published: 2002-11-14

Total Pages: 456

ISBN-13: 9780415285018

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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.

Handbook of Industrial Chemistry and Biotechnology

Handbook of Industrial Chemistry and Biotechnology PDF

Author: James A. Kent

Publisher: Springer Science & Business Media

Published: 2013-01-13

Total Pages: 1560

ISBN-13: 1461442591

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Substantially revising and updating the classic reference in the field, this handbook offers a valuable overview and myriad details on current chemical processes, products, and practices. No other source offers as much data on the chemistry, engineering, economics, and infrastructure of the industry. The Handbook serves a spectrum of individuals, from those who are directly involved in the chemical industry to others in related industries and activities. It provides not only the underlying science and technology for important industry sectors, but also broad coverage of critical supporting topics. Industrial processes and products can be much enhanced through observing the tenets and applying the methodologies found in chapters on Green Engineering and Chemistry (specifically, biomass conversion), Practical Catalysis, and Environmental Measurements; as well as expanded treatment of Safety, chemistry plant security, and Emergency Preparedness. Understanding these factors allows them to be part of the total process and helps achieve optimum results in, for example, process development, review, and modification. Important topics in the energy field, namely nuclear, coal, natural gas, and petroleum, are covered in individual chapters. Other new chapters include energy conversion, energy storage, emerging nanoscience and technology. Updated sections include more material on biomass conversion, as well as three chapters covering biotechnology topics, namely, Industrial Biotechnology, Industrial Enzymes, and Industrial Production of Therapeutic Proteins.