Nonclinical Development of Biologics, Vaccines and Specialty Biologics

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

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• Toxicologia médica

<p>Biopharmaceuticals; Biologics; Vaccines; Gene Therapy; Antibody-drug Conjugates; Cancer Therapeutics; Pharmacology; Pharmacokinetics; Nonclinical; Regulatory; Safety; Nonclinical safety assessment</p>