Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
Publisher: elsevier
Published: 2013
Language: eng
ISBN-13: 9780123948106
Table of contents: title: Preface; title: Acknowledgement; title: Dedication; title: Section I: Biopharmaceuticals; title: 1. Novel Biopharmaceuticals; title: 2. Global Regulatory Guidances; title: 3. Early de-risking strategies for Novel Biopharmaceuticals vs. Small Molecule Drugs; title: 4. PK/PD assessments and Assays; title: 5. Antibody-Drug Conjugates; title: Section II: Biosimilar Therapeutics; title: 6. Description of Biosimilar Therapeutics and  Compare/contrast Biosimilar Therapeuticss and Novel Biopharmaceuticals; title: 7. Global Regulatory Guidelines; title: 8. Early characterization of Biosimilar Therapeutics vs. Novel Biopharmaceuticals/Studies Required and Principles of Study Design/PK/PD assessments/Assays; title: Section III: Vaccines; title: 9. Vaccines Description and Comparison/Contrast of Vaccines and Novel Biopharmaceuticals; title: 10. Global Regulatory Guidances; title: 11. Early de-risking strategies for Vaccines vs. Novel Biopharmaceuticals; title: Section IV: Specialty Biologics and Indications; title: 12. Cell Therapies; title: 13. Gene Therapies; title: 14. Blood Products; title: 15. Oncology Drugs; title: 16. Dual and Multi-Function Modalities; title: 17. Stem Cell-Based Therapeutics