Nonclinical Development of Biologics, Vaccines and Specialty Biologics（2）

著者名：Plitnick, Lisa M. (EDT)/Fuller, Claudette L. (EDT)

Academic Press（2024/11/16発売）

• 言語：ENG
• ISBN：9780443133442
• eISBN：9780443133459

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

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