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Full Description
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. 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. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics.
Contents
Preface
Acknowledgement
Dedication
Section I: Biopharmaceuticals
1. Novel Biopharmaceuticals
2. Global Regulatory Guidances
3. Early de-risking strategies for Novel Biopharmaceuticals vs. Small Molecule Drugs
4. PK/PD assessments and Assays
5. Antibody-Drug Conjugates
Section II: Biosimilar Therapeutics
6. Description of Biosimilar Therapeutics and Compare/contrast Biosimilar Therapeuticss and Novel Biopharmaceuticals
7. Global Regulatory Guidelines
8. Early characterization of Biosimilar Therapeutics vs. Novel Biopharmaceuticals/Studies Required and Principles of Study Design/PK/PD assessments/Assays
Section III: Vaccines
9. Vaccines Description and Comparison/Contrast of Vaccines and Novel Biopharmaceuticals
10. Global Regulatory Guidances
11. Early de-risking strategies for Vaccines vs. Novel Biopharmaceuticals
Section IV: Specialty Biologics and Indications
12. Cell Therapies
13. Gene Therapies
14. Blood Products
15. Oncology Drugs
16. Dual and Multi-Function Modalities
17. Stem Cell-Based Therapeutics
