Nonclinical Development of Biologics, Vaccines and Specialty Biologics

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. This multi-edited book with chapters authored by leading qualified experts in the field offers a comprehensive reference on critical insights that will be of interest to 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 biopharmaceuticalContains the most pertinent international regulatory guidance documents for nonclinical evaluationCovers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or biosimilarsUpdated and revised, with new chapters on nonclinical development of monovalent and polyvalent biopharmaceuticals; pharmacokinetics, pharmacodynamics, and bioanalytics; regulatory expectations and early characterization of biosimilar therapeutics; and cell and gene therapies INDICE: 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 6. Overview, Regulatory Expectations and Early Characterization of Biosimilar Therapeutics Section II: Vaccines 7. Introduction to Vaccines and Adjuvants 8. Global Regulatory Guidelines for Vaccines 9. Special Considerations for the Nonclinical Safety Assessment of Vaccines Section III: Specialty Biologics and Indications 10. Gene Therapy 11. Cell Therapy 12. Biological Therapies for Cancer 13. Considerations in the Development of Pluripotent Stem Cell-based Therapies

• ISBN: 978-0-443-13344-2
• Editorial: Academic Press
• Encuadernacion: Cartoné
• Páginas: 450
• Fecha Publicación: 01/11/2024
• Nº Volúmenes: 1
• Idioma: Inglés