Description
Nonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics, Second Edition is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products.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. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. A multi-edited book with chapters authored by leading qualified experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late-stage biologics.- Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical- Discusses the most pertinent international regulatory guidelines- Covers early derisking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines
Table of Contents
PrefaceSection I: Development of Biopharmaceuticals1. Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development2. Nonclinical Development of Monovalent and Polyvalent Biopharmaceuticals3. Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological Medicines4. Early De-risking Strategy for Novel Biotherapeutics5. Pharmacokinetics, Pharmacodynamics, and BioanalyticsSection II: Vaccines6. Introduction to Vaccines and Adjuvants7. Global Regulatory Guidelines for Vaccines8. Special Considerations for the Nonclinical Safety Assessment of VaccinesSection III: Specialty Biologics and Indications9. Gene Therapy10. Cell Therapy11. Biological Therapies for Cancer12. Considerations in the Development of Pluripotent Stem Cell-based Therapies
