| Description |
1 online resource (544 pages). |
| Physical Medium |
polychrome |
| Description |
text file |
| Series |
Drug discovery series ; 72
|
|
RSC drug discovery series ; 72.
|
| Note |
Includes index. |
| Contents |
Cover; Preface; Editor Biography; Contents; Chapter 1 Regulatory Considerations for Peptide Therapeutics; 1.1 Introduction; 1.2 Peptide Quality Assessment at the FDA; 1.3 Overview of the Current Drug Approval Process Employed for Peptide Applications; 1.3.1 The New Drug Application Assessment Process; 1.3.2 Abbreviated New Drug Application Assessment Process; 1.3.3 Post-approval Activities and Life-cycle Management; Disclaimer; Acknowledgements; References; Chapter 2 Regulatory Perspective on Synthetic Peptides in Europe; 2.1 Introduction; 2.2 European Regulatory Network |
|
2.3 Guidelines on the Quality of Human Medicines2.4 Overall Control Strategy; 2.5 Documentation in Dossier of Marketing Authorization; 2.6 European Pharmacopoeia (Ph. Eur.); 2.7 Technical Guide for the Elaboration of Monographson Synthetic Peptides and Recombinant DNA Proteins; 2.8 Information to be Provided in Module 3 for Synthetic Peptides (New Active Substances); 2.9 Considerations for Peptides Conjugates; 2.10 Medicinal Product Considerations; 2.11 Synthetic Peptide Vaccines |
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2.12 Synthetic Peptide Development Programmes Using a Biological Medicinal Product as a European Reference Medicinal Product2.13 Requirements for Clinical Trial Applications; 2.14 Scientific Advice and European Initiatives for Early Access Approaches; 2.15 Conclusion; Disclaimer; References; Chapter 3 Biological and Immunogenicity Evaluation Strategy for Therapeutic Peptides: Chemistry, Manufacturing and Controls Perspective; 3.1 Introduction; 3.2 Biological Evaluation; 3.2.1 Strategy for Assay Development; 3.2.2 Considerations for Potency Assay Design and Validation |
|
3.3 Assay Development and Validation3.3.1 Ex Vivo Bioassays; 3.3.2 In Vitro Bioassays; 3.3.3 Assay Readouts; 3.3.4 Assay Design; 3.3.5 Cell Line Selection; 3.3.6 Factors Influencing the Assays; 3.3.7 Standards and Controls; 3.3.8 Design of Experiments and Data Analysis; 3.3.9 Assay Validation; 3.4 Specific Assays of Peptide-based Vaccines; 3.4.1 HLA Binding Assays; 3.5 Immunogenicity Evaluation; 3.5.1 Antibody Testing Strategy; 3.5.2 Risk-based Antibody Testing; 3.5.3 Binding Antibody Testing; 3.5.4 Sandwich Immunoassay; 3.5.5 Mass-related Immunoassay; 3.5.6 SPR; 3.5.7 Mass Spectrometry |
|
3.5.8 Cytometry-based Immunoassays3.5.9 Acid Dissociation-based Assay for Drug Interference; 3.5.10 Considerations for Binding Antibody Immunoassays; 3.6 Neutralizing Anti-drug Antibody Testing; 3.6.1 Cell-based Neutralizing Antibody Assay; 3.6.2 Cell Line Selection; 3.6.3 Assay Endpoints for Cell-based Assays; 3.6.4 Cell-based Assay Formats; 3.6.5 Considerations for Ligand-binding Antibody Bioassays; 3.7 Specific Assays for Peptide-based Vaccines; 3.7.1 Enzyme-linked Immunospot (ELISpot) Assay; 3.7.2 Surface and Intracellular Staining; 3.8 Conclusion; References |
| Summary |
Peptide Therapeutics is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about Chemistry Manufacture and Control (CMC), and facilitating the development and manufacture of peptide-based drugs. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
Peptide drugs.
|
|
Peptide drugs. |
|
Peptide drugs -- Development.
|
| Genre/Form |
Electronic books.
|
| Added Author |
Srivastava, Ved, editor.
|
| Other Form: |
Print version : 9781788014335 |
| ISBN |
9781788016445 (electronic book) |
|
1788016440 (electronic book) |
|
9781788018692 (electronic book) |
|
1788018699 |
|
9781788014335 (print) |
|
1788014332 (print) |
|
