Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
Academic Press Inc (Verlag)
978-0-12-394810-6 (ISBN)
- Titel erscheint in neuer Auflage
- Artikel merken
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.
Dr. Lisa Plitnick received a BA in Biology from The State University of New York at Oswego and an MS and a PhD in Immunology from the Albany Medical College in Albany, New York. In 2002, she joined the Department of Safety Assessment and Laboratory Animal Resources in Merck Research Laboratories where she worked as a Study Director and currently serves as the Preclinical Safety Lead on drug development teams and as the Therapeutic Area Lead for Vaccines. She is the Scientific and Regulatory Advisor for the In Vivo Biologics Release Testing Group in the Merck Manufacturing Division and the Scientific Advisor for the Immunotoxicology Laboratory. Dr. Plitnick has edited a book, contributed to several book chapters on biologics and vaccines, and peer-reviewed journal articles. She is a member of the HESI ILSI Immunotoxicology Technical Committee, the BioSafe Specialty Biologics Expert and MoA/MoT working groups, and the Merck Immunotoxicology Council.
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
| Verlagsort | San Diego |
|---|---|
| Sprache | englisch |
| Maße | 191 x 235 mm |
| Gewicht | 1070 g |
| Themenwelt | Naturwissenschaften |
| Technik | |
| ISBN-10 | 0-12-394810-X / 012394810X |
| ISBN-13 | 978-0-12-394810-6 / 9780123948106 |
| Zustand | Neuware |
| Haben Sie eine Frage zum Produkt? |
aus dem Bereich
