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...
List of Illustrations
1 Chapter 3Figure 3.1 Relative molecular mass of small molecule and biologic drugs.
2 Chapter 4Figure 4.1 Structure of IgG1. (a) Schematic representation of an IgG1 displa...Figure 4.2 Structural features of various classes of therapeutic proteins.
3 Chapter 5Figure 5.1 CTLA‐4 and PD‐1/PD‐L1 blockade using immune checkpoint inhibitors...Figure 5.2 Extracellular domain structures of EGFR bound to EGF (PDB ID: 3NJ...Figure 5.3 Mechanism of action of TNF‐α biologics; infliximab is shown bindi...
4 Chapter 6Figure 6.1 (a) Primary, secondary, tertiary, and quaternary protein structur...Figure 6.2 Types of N‐glycans observed in therapeutic proteins. All N‐glycan...Figure 6.3 Post‐translational γ‐carboxylation of glutamate residues in prote...Figure 6.4 An IgG1 antibody with 4 interchain (green) and 12 intra‐chain dis...Figure 6.5 Native and non‐native protein aggregation.Figure 6.6 Different size particles present in an influenza vaccine sample a...
5 Chapter 7Figure 7.1 Development paradigm of biosimilars versus innovators.Figure 7.2 Quality attribute ranges of a biosimilar candidate and its refere...Figure 7.3 Time line of EMA and FDA biosimilar approvals.Figure 7.4 Elements of the optimal switching study and study designs employe...
6 Chapter 8Figure 8.1 Graph summarizing the pharmacokinetic features of therapeutic pro...Figure 8.2 Schematic summarizing the many unique factors that influence the ...Figure 8.3 The process of receptor‐mediated endocytosis and FcRn recycling o...Figure 8.4 The impact of antidrug antibodies on the pharmacokinetics and pha...
7 Chapter 13Figure 13.1 CAR T‐cell therapy treatment.Figure 13.2 Cartoon illustration of the evolution of CAR‐T therapies.Figure 13.3 Comparison of MultiTAA and CAR T‐cell therapy.Figure 13.4 Antagonism of immune checkpoint receptors.
8 Chapter 15Figure 15.1 Pharmacy curriculum reform framework on biologics.
Guide
2 Biologics, Biosimilars, and Biobetters
5 Foreword
6 Preface
9 Index
10 WILEY END USER LICENSE AGREEMENT
Pages
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