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Nonclinical development of novel biologics, biosimilars, vaccines and specialty biologics /
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types...
| Clasificación: | Libro Electrónico |
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| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London, UK :
Elsevier, AP, Academic Press is an imprint of Elsevier,
[2013]
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Front Cover; Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics; Copyright; Dedication; Contents; Preface; Contributors; Acknowledgments; Section I Development of Biopharmaceuticals Defined as Novel Biologics; Chapter 1
- Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development; INTRODUCTION; HISTORY AND EVOLUTION OF BIOPHARMACEUTICALS; DEVELOPMENT OF DIVERSE BIOPHARMACEUTICAL MODALITIES; COMPARISON OF SMALL-MOLECULE DRUGS TO BIOPHARMACEUTICALS; SUMMARY; References.
- Chapter 2
- Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological MedicinesINTRODUCTION; SPECIES SELECTION; STUDY DESIGN CONSIDERATIONS FOR REPEAT-DOSE STUDIES; IMMUNOGENICITY; REPRODUCTIVE AND DEVELOPMENTAL TOXICITY; GENOTOXICITY AND CARCINOGENICITY; SPECIAL CONSIDERATIONS FOR ANTICANCER DRUGS; FIRST-IN-HUMAN (FIH) CLINICAL TRIAL; SUMMARY; References; Chapter 3
- Early De-risking Strategy for Novel Biotherapeutics; INTRODUCTION; ESTABLISHING A SAFETY PROFILE FOR BIOTHERAPEUTICS; GENERAL SAFETY CONSIDERATIONS RELATED TO BIOTHERAPEUTICS.
- PROGRESS IN EVALUATION OF IMMUNOTOXICITYCAN WE BETTER ADDRESS POTENTIAL OFF-TARGET TOXICITY?; SUMMARY; References; Chapter 4
- Novel Biopharmaceuticals: Pharmacokinetics, Pharmacodynamics, and Bioanalytics; INTRODUCTION; ABSORPTION, DISTRIBUTION AND ELIMINATION OF BIOPHARMACEUTICALS; DISPOSITION OF MODIFIED MOLECULES; "METABOLISM" AND BIODISTRIBUTION FOR BIOPHARMACEUTICALS; IMMUNOGENICITY AND IMPACTS ON PK AND BIODISTRIBUTION; PHARMACOKINETICS AND PHARMACODYNAMICS; PRECLINICAL TO CLINICAL TRANSLATION; BIOANALYTICS; DRUG ASSAYS; BIOMARKERS: TARGET ENGAGEMENT ASSAYS.
- IMMUNOGENICITY ASSESSMENT: ADA ASSAYSSUMMARY; References; Section II Development of Biosimilars; Chapter 5
- Overview of Biosimilar Therapeutics; INTRODUCTION; THE CONCEPT OF BIOSIMILARS; GENERAL CONSIDERATIONS FOR DEVELOPMENT OF BIOSIMILARS; BIOSIMILAR CANDIDATES BASED ON MODALITY AND THERAPEUTIC CLASS; SUMMARY; References; Chapter 6
- Regulatory Standards for the Approval of Biosimilar Products: A Global Review; INTRODUCTION; EUROPEAN UNION-PIONEER FOR THE FIRST REGULATORY PATHWAY FOR BIOSIMILAR PRODUCTS; THE WORLD HEALTH ORGANIZATION GUIDANCE ON BIOSIMILARS.
- REGULATORY PATHWAY FOR BIOSIMILAR PRODUCTS IN THE UNITED STATESBIOSIMILAR PATHWAYS IN OTHER REGIONS; SUMMARY; References; Chapter 7
- Early Characterization of Biosimilar Therapeutics; INTRODUCTION; RECOMBINANT INSULINS; RECOMBINANT HUMAN GROWTH HORMONE; RECOMBINANT ERYTHROPOIETINS; RECOMBINANT GRANULOCYTE COLONY-STIMULATING FACTOR; RECOMBINANT INTERFERONS; LOW MOLECULAR WEIGHT HEPARINS; MONOCLONAL ANTIBODIES; OTHER CLASSES; SUMMARY; References; Section III Vaccines; Chapter 8
- Introduction to Vaccines and Adjuvants; INTRODUCTION; THE HISTORY OF VACCINES.