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
...
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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