Nonclinical Development of Biologics, Vaccines and Specialty Biologics

ISBN-13: 9780443133442 / Angielski

Lisa Plitnick; Claudette Latonya Fuller

Spis treści

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