Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Erscheinungsjahr 2013
ISBN: 978-0-12-394810-6
Verlag: William Andrew Publishing

Buch, Englisch, 432 Seiten, Format (B × H): 191 mm x 235 mm, Gewicht: 1070 g

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.

Zielgruppe

<p>Pharmaceutical scientists, toxicologists, geneticists, biochemists, cell biologists and immunologists working in the area of biologics within academia, small biotechnology and large pharmaceutical companies. </p>

Autoren/Hrsg.

Plitnick, Lisa M.

Herzyk, Danuta

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Vorklinische Medizin: Grundlagenfächer Molekulare Medizin, Zellbiologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Klinische und Innere Medizin Immunologie
• Naturwissenschaften Biowissenschaften Zellbiologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Naturwissenschaften Biowissenschaften Biowissenschaften Genetik und Genomik (nichtmedizinisch)
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Vorklinische Medizin: Grundlagenfächer Humangenetik

Inhaltsverzeichnis

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

Über Autor(innen)

Plitnick, Lisa M.
Dr. Lisa M. Plitnick is a Distinguished Scientist in Nonclinical Drug Safety, Merck Research Laboratories, Merck and Co., Inc. Lisa joined Merck in 2002 and currently serves as the Therapeutic Area Lead for Vaccines and a Nonclinical Safety Leader on vaccine and biologic development teams spanning early and late development. Lisa is also the Scientific and Regulatory Advisor for the in Vivo Biologics Release Testing Group in the Merck Manufacturing Division. Lisa co-edited the first edition of this book, Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics and has written and/or contributed to book chapters and peer-reviewed journal articles on biologics and vaccines. Lisa received a M.S. and Ph.D. in Immunology from the Albany Medical College. Following her graduate work she did a postdoctoral fellowship with a focus on Immunotoxicology in the Curriculum in Toxicology at the University of North Carolina in cooperation with the US Environmental Protection Agency, Dow Chemical and DuPont.