Full Description
Nonclinical Development of Biologics, Vaccines and Specialty Biologics, Second Edition, is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, vaccines, cell and gene therapies, and oncology therapeutics. Updated and revised, the new edition compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory guidelines. This book discusses the different types of biologics, as well as early characterization strategies, principles of study design, nonclinical pharmacokinetics and pharmacodynamics, nonclinical assays, and regulatory guidelines. A coedited book with chapters authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late-stage biologics.
Contents
Preface
Section I: Development of Biopharmaceuticals
1. Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development
2. Nonclinical Development of Monovalent and Polyvalent Biopharmaceuticals
3. Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological Medicines
4. Early De-risking Strategy for Novel Biotherapeutics
5. Pharmacokinetics, Pharmacodynamics, and Bioanalytics
Section II: Vaccines
6. Introduction to Vaccines and Adjuvants
7. Global Regulatory Guidelines for Vaccines
8. Special Considerations for the Nonclinical Safety Assessment of Vaccines
Section III: Specialty Biologics and Indications
9. Gene Therapy
10. Cell Therapy
11. Biological Therapies for Cancer
12. Considerations in the Development of Pluripotent Stem Cell-based Therapies
