Pharmaceutical Biotechnology In Drug Development
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Pharmaceutical Biotechnology
- Author : Oliver Kayser,Heribert Warzecha
- Publisher : John Wiley & Sons
- Release Date : 2012-05-21
- Total pages : 677
- ISBN : 9783527329946
- File Size : 41,6 Mb
- Total Download : 196
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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
- Author : Gary Walsh
- Publisher : John Wiley & Sons
- Release Date : 2013-04-25
- Total pages : 504
- ISBN : 9781118685754
- File Size : 32,8 Mb
- Total Download : 553
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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
Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems
- Author : Ashok Katdare,Mahesh Chaubal
- Publisher : CRC Press
- Release Date : 2006-07-28
- Total pages : 452
- ISBN : 9781420004137
- File Size : 25,9 Mb
- Total Download : 715
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To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed and approved continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge new avenue
Career Opportunities in Biotechnology and Drug Development
- Author : Toby Freedman
- Publisher : CSHL Press
- Release Date : 2008
- Total pages : 408
- ISBN : 9780879697259
- File Size : 14,5 Mb
- Total Download : 789
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An essential guide for students in the life sciences, established researchers, and career counselors, this resource features discussions of job security, future trends, and potential career paths. Even those already working in the industry will find helpful information on how to take advantage of opportunities within their own companies and elsewhere.
Biotechnology and Biopharmaceuticals
- Author : Rodney J. Y. Ho,Milo Gibaldi
- Publisher : John Wiley & Sons
- Release Date : 2004-09-21
- Total pages : 577
- ISBN : 9780471450276
- File Size : 35,5 Mb
- Total Download : 846
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Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs defines biotechnology from the perspective of pharmaceuticals. The first section focuses on the process of transforming a biologic macromolecule into a therapeutic agent, while the second section provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. Additional detail is also provided in the second section for each FDA approved, recombinantly derived biopharmaceutical for each category of macromolecule. The final section looks to the future and the new advances that will enhance our ability to develop new macromolecules into effective biopharmaceuticals. This last section discusses various drug delivery strategies while also describing gene and cell therapy strategies.
Advances in Pharmaceutical Biotechnology
- Author : Jayanta Kumar Patra,Amritesh C. Shukla,Gitishree Das
- Publisher : Springer Nature
- Release Date : 2020-03-30
- Total pages : 478
- ISBN : 9789811521959
- File Size : 38,6 Mb
- Total Download : 466
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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.
Biotechnology and Biopharmaceuticals
- Author : Anonim
- Publisher : John Wiley & Sons
- Release Date : 2013-12-16
- Total pages : 744
- ISBN : 9781118179796
- File Size : 40,5 Mb
- Total Download : 888
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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.
Pharmaceutical Biotechnology
- Author : Carlos A. Guzmán,Giora Z. Feuerstein
- Publisher : Springer Science & Business Media
- Release Date : 2010-01-01
- Total pages : 276
- ISBN : 9781441911322
- File Size : 21,6 Mb
- Total Download : 464
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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 and vaccines 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
- Author : Daan J. A. Crommelin,Robert D. Sindelar,Bernd Meibohm
- Publisher : Springer Science & Business Media
- Release Date : 2013-10-22
- Total pages : 544
- ISBN : 9781461464860
- File Size : 20,8 Mb
- Total Download : 108
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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.
Development and Manufacture of Protein Pharmaceuticals
- Author : Steve L. Nail,Michael J. Akers
- Publisher : Springer Science & Business Media
- Release Date : 2012-12-06
- Total pages : 464
- ISBN : 9781461505495
- File Size : 41,6 Mb
- Total Download : 607
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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.
Pharmacokinetics and Pharmacodynamics of Biotech Drugs
- Author : Bernd Meibohm
- Publisher : John Wiley & Sons
- Release Date : 2006-12-13
- Total pages : 426
- ISBN : 9783527609529
- File Size : 48,5 Mb
- Total Download : 849
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This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.
The Science and Business of Drug Discovery
- Author : Edward D. Zanders
- Publisher : Springer Nature
- Release Date : 2020-11-09
- Total pages : 402
- ISBN : 9783030578145
- File Size : 33,7 Mb
- Total Download : 796
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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
Introduction to Pharmaceutical Biotechnology, Volume 1
- Author : Saurabh Bhatia,Divakar Goli
- Publisher : Unknown
- Release Date : 2018-05-23
- Total pages : 320
- ISBN : 0750319658
- File Size : 52,5 Mb
- Total Download : 578
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Animal biotechnology is a broad field including polarities of fundamental and applied research, as well as DNA science, covering key topics of DNA studies and its recent applications. In Introduction to Pharmaceutical Biotechnology, DNA isolation procedures followed by molecular markers and screening methods of the genomic library are explained in detail. Interesting areas such as isolation, sequencing and synthesis of genes, with broader coverage of the latter, are also described. The book begins with an introduction to biotechnology and its main branches, explaining both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It then moves on to the historical development and scope of biotechnology with an overall review of early applications that scientists employed long before the field was defined. Additionally, this book offers first-hand accounts of the use of biotechnology tools in the area of genetic engineering and provides comprehensive information related to current developments in the following parameters: plasmids, basic techniques used in gene transfer, and basic principles used in transgenesis. The text also provides the fundamental understanding of stem cell and gene therapy, and offers a short description of current information on these topics as well as their clinical associations and related therapeutic options.
Integration of Pharmaceutical Discovery and Development
- Author : Ronald T. Borchardt,Roger M. Freidinger,Tomi K. Sawyer,Philip L. Smith
- Publisher : Springer Science & Business Media
- Release Date : 2006-01-19
- Total pages : 627
- ISBN : 9780306473845
- File Size : 49,7 Mb
- Total Download : 657
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In the late 1980s, it became painfully evident to the pharmaceutical industry that the old paradigm of drug discovery, which involved highly segmented drug - sign and development activities, would not produce an acceptable success rate in the future. Therefore, in the early 1990s a paradigm shift occurred in which drug design and development activities became more highly integrated. This new str- egy required medicinal chemists to design drug candidates with structural f- tures that optimized pharmacological (e. g. , high affinity and specificity for the target receptor), pharmaceutical (e. g. , solubility and chemical stability), bioph- maceutical (e. g. , cell membrane permeability), and metabolic/pharmacokinetic (e. g. , metabolic stability, clearance, and protein binding) properties. Successful implementation of this strategy requires a multidisciplinary team effort, incl- ing scientists from drug design (e. g. , medicinal chemists, cell biologists, en- mologists, pharmacologists) and drug development (e. g. , analytical chemists, pharmaceutical scientists, physiologists, and molecular biologists representing the disciplines of pharmaceutics, biopharmaceutics, and pharmacokinetics/drug metabolism). With this new, highly integrated approach to drug design now widely utilized by the pharmaceutical industry, the editors of this book have provided the sci- tific community with case histories to illustrate the nature of the interdisciplinary interactions necessary to successfully implement this new approach to drug d- covery. In the first chapter, Ralph Hirschmann provides a historical perspective of why this paradigm shift in drug discovery has occurred.
Pharmaceutical Biotechnology
- Author : Oliver Kayser,Rainer H. Müller
- Publisher : Wiley-Blackwell
- Release Date : 2004-04-12
- Total pages : 336
- ISBN : 3527305548
- File Size : 24,5 Mb
- Total Download : 192
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PDF book entitled Pharmaceutical Biotechnology written by Oliver Kayser,Rainer H. Müller and published by Wiley-Blackwell which was released on 2004-04-12 with total hardcover pages 336, the book become popular and critical acclaim.
Biopharmaceutical Drug Design and Development
- Author : Susanna Wu-Pong
- Publisher : Springer Science & Business Media
- Release Date : 1999-04-01
- Total pages : 436
- ISBN : 9781592597055
- File Size : 31,6 Mb
- Total Download : 846
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New discoveries in biology are occurring at an incredible rate, and with these discoveries arise nearly unimaginable opportunities in every area of human existence. Imagine the excitement surround ing the "penicillin project" and the subsequent rapid development of anti-infective agents that took place in the 1940s and 1950s. Fast for ward to the world today and our ability to treat life-threatening infec tions. This is but one small piece in the present kaleidoscope of new therapeutic agents. In fact, the world of science, biology, and medi cine is changing so quickly that it is difficult for scientists and medi cal practitioners to stay abreast of their fields and confidently anticipate that their education and training will sustain them over a three- to four-decade career without considerable continuing educa tion and training. For the pharmaceutical scientist responsible for the discovery and development of therapeutic agents based on advances in biotechnology, it is imperative to quickly come up to speed and stay at the forefront of developments, which is no easy task for those not specifically trained in this area. Biopharmaceutical Drug Design and Development, edited by Susanna Wu-Pong and Yongyut Rojanasakul, cuts a potentially wide swath in terms of its intended audience. It clearly is a primer for those not trained in the area, or for those who wish to be brought into the mainstream of drug discovery and development in the world of bio technology.
Pharmaceutical Biotechnology in Drug Development
- Author : Muhammad Sajid Hamid Akash,Kanwal Rehman,Kanwal Irshad,Shuqing Chen
- Publisher : Elsevier
- Release Date : 2023-05-05
- Total pages : 238
- ISBN : 9780443191367
- File Size : 46,5 Mb
- Total Download : 641
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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
Biopharmaceuticals
- Author : Gary Walsh
- Publisher : John Wiley & Sons
- Release Date : 2013-04-29
- Total pages : 544
- ISBN : 9781118687383
- File Size : 36,7 Mb
- Total Download : 730
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The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.
Rare Diseases and Orphan Products
- Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
- Publisher : National Academies Press
- Release Date : 2011-04-03
- Total pages : 442
- ISBN : 9780309158060
- File Size : 21,6 Mb
- Total Download : 968
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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Handbook of Pharmaceutical Biotechnology
- Author : Jay P Rho,Stan G Louie
- Publisher : CRC Press
- Release Date : 2003-03-31
- Total pages : 214
- ISBN : 0789016354
- File Size : 45,9 Mb
- Total Download : 942
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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.
The Process of New Drug Discovery and Development
- Author : G. Smith Charles
- Publisher : CRC Press
- Release Date : 1992-08-24
- Total pages : 166
- ISBN : 0849342112
- File Size : 46,7 Mb
- Total Download : 146
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The Process of New Drug Discovery and Development presents a practical methodology for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It includes detailed discussions regarding the research process and presents critiques of the governmental regulatory aspects of pharmaceutical research. The author also addresses the controversy surrounding the use of animals in biomedical research and provides current information regarding the field of biotechnology, international drug research, and registration activities. The Process of New Drug Discovery and Development is an excellent "how to" text for pharmaceutical researchers, oncologists, biochemists, experimental biologists, and others involved in new drug research and development.