Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 3

1 Chapter 1Table 1.1 Broad categories of biologic medicines.Table 1.2 Definitions of biosimilars by major regulatory agencies.Table 1.3 Pivotal differences between biologics and small molecule drugs.Table 1.4 Abbreviations used in biologic medicine literature.

2 Chapter 3Table 3.1 Best‐selling drugs ranked by sales volume.Table 3.2 Characteristics of small molecule pharmaceuticals vs. biologics.Table 3.3 Preclinical and clinical trial data exclusivity by nation.Table 3.4 A history of vaccine development and regulation in the United State...Table 3.5 Examples of cytokine drugs and diseases treated.Table 3.6 Insulin: timeline of discovery and manufacture.

3 Chapter 4Table 4.1 Major classes of biotherapeutics.

4 Chapter 6Table 6.1 Comparison of common characteristics of biologics and small molecul...Table 6.2 Nomenclature/naming of therapeutic monoclonal antibodies.Table 6.3 Summary of commonly used biophysical methods used in biologics rese...

5 Chapter 7Table 7.1 Representative example of quality attributes for a monoclonal antib...

6 Chapter 8Table 8.1 Monoclonal antibody nomenclature, humanized component, and examples...Table 8.2 Pharmaceutical, pharmacokinetic, and pharmacodynamic differences be...Table 8.3 Pharmacokinetic parameters for selected therapeutic proteins includ...Table 8.4 Examples of monoclonal antibodies with membrane‐bound and shed targ...Table 8.5 Drug interactions involving monoclonal antibodies.^2,49

7 Chapter 10Table 10.1 Comparison of biosimilar regulations and guidelines internationall...

8 Chapter 11Table 11.1 Pharmacovigilance signal refinement.⁴¹Table 11.2 Advantages and limitations of spontaneous reporting systems.⁵⁴

9 Chapter 12Table 12.1 Examples of incentives and disincentives for biosimilar adoption.

10 Chapter 13Table 13.1 Some critical properties of approved antibody–drug conjugates (ADC...Table 13.2 Current immune checkpoint inhibitors in clinical use.

11 Chapter 14Table 14.1 Considerations for PTC members evaluating biosimilars for formular...Table 14.2 Steps for implementation of an interchangeability program for bios...

12 Chapter 15Table 15.1 Core knowledge areas for pharmacists and pharmacy students.

13 Chapter 16Table 16.1 Summary information on selected biologic therapies.^{1, 2, 5, 7, 20–}...Table 16.2 Regulatory differences – comparison of biosimilars and generics of...Table 16.3 The principles of naming monoclonal antibodies.³⁵Table 16.4 An example of infliximab listing on the Pharmaceutical Benefits Sc...Table 16.5 Checklist for pharmacists for safe and effective use of biologic t...