EBOOK - Biotechnology and Biopharmaceuticals Transforming Proteins and Genes into Drugs (Rodney J. Y. Ho)

EBOOK - Công nghệ sinh học và các dược phẩm sinh học biến đổi protein và gien thành chất gây nghiện (Rodney J. Y. Ho) - 741 Trang.

When asked for a foreword to the 2013 second edition of Ho and Gibaldi’s Biotechnology and Biopharmaceuticals; Transforming Proteins and Genes into Drugs, my first response was, who me? I have not actively engaged in the discovery and development of biopharmaceuticals, nor am I an active practitioner using these important medicines. Yet all of us, including me, are witnesses to the revolutionary advances in biopharmaceuticals chronicled in the second edition. So perhaps anyone could write this foreword and would be, as I am, honored to do so.

My second question was, did I have to follow the typical pattern of writing a foreword that few would read and might even be considered boring? Or would it be possible to speak more directly, perhaps to an audience that would include the social media crowd? What if I were writing to the kids of today, and by kids I mean some of the readers of the second edition? Would it be possible to write something that would capture their fleeting attention as they peer myopically into small handheld screens? Well that is a challenge - how to capture the scientific and societal miracles of recent decades in 140 characters. As a start, I refer readers to the table of contents of the second edition, which (after suitable translation for the non-cognoscenti) not only speaks to drama, intrigue, and danger the stuff of a Hollywood thriller but also opens the door to fantastical visions of the future that are the stuff of science fiction.

1 introduction to biopharmaceuticals  3
Abstract  3
1.1  Background and Significance  4
1.2  Translation of Biotechnology for Developing Biopharmaceuticals  7
1.3  Historical Perspective of Pharmaceutical Biotechnology  8
1.4  Distinctions between Chemical Drugs Versus Biopharmaceuticals  8
1.5  Summary  10
2 distinctions of biologic Versus Small Molecule Platforms in drug evelopment  13
Abstract  13
2.1  Introduction  14
2.2  Transforming New Molecules into Drugs: The Drug Development Process  14
2.3  Key Differences between Biotechnology and Chemical Products  16
2.4  Current Trends in Drug Development  18
2.5  Summary  22
3 Financing biologic drug development  23
Abstract  23
3.1  Introduction  24
3.2  The Role of the Orphan Drug Act  27
3.3  Clinical Leverage Strategy in Accelerating Drug Development  30
3.4  Therapeutic Target Considerations  32
3.5  Evolving Trends  34
3.6  Summary  36
4  Application of biotechnology in drug discovery and early development  39
Abstract  39
4.1  Introduction  40
4.2  Data Mining, Molecular Cloning, and Characterization  40
4.3  Optimization of Cell Expression Systems and Product Yield  50
4.4  Molecular Optimization  51
4.5  Proteins and Genes as Targets for Drug Discovery and Development  56
4.6  Summary  58
5 large-Scale Production of Recombinant Proteins  63
Abstract  63
5.1  Introduction  64
5.2  Yield Optimization in Genetic Constructs and Host Cells  65
5.3  Large-Scale Cultivation of Host Cells  66
5.4  Downstream Processing and Purification  70
5.5  Quality Assurance and Quality Control  75
5.6  Summary  77
6  clinical Pharmacology, toxicology, and therapeutic dosage and Response  79
Abstract  79
6.1  Introduction  80
6.2  Clinical Pharmacology and Toxicology  80
6.3  Dose and Therapeutic Response  95
6.4  Dosage Form and Route of Administration  97
6.5  Summary  99
7 clinical evaluation and Regulatory Approval and enforcement of biopharmaceuticals  103
Abstract  103
7.1  Introduction: Biologic Drug Development and Approval  104
7.2  Licensing of Biological Products  104
7.3  Preclinical and Clinical Testing  107
7.4  FDA Review and Approval Process  114
7.5  Regulatory Enforcement  118
7.6  Globalization of Drug Approval (Chien*)  118
7.7  Summary  122
8 Pharmacoeconomics and drug Pricing (Garrison*)  125
Abstract  125
8.1  Introduction: Pharmacoeconomics  126
8.2  Cost-Effectiveness: Assessing the Value of Biopharmaceuticals  126
8.3  The Cost of Developing Biopharmaceuticals  128
8.4  Pricing Biopharmaceuticals  131
8.5  Drug Development Incentives  133
8.6  Economics of Biosimilars  133
8.7  Economic Impact of Personalized Medicine  134
8.8  Summary and Future Challenges  135


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