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

Edited by

  • Lisa Plitnick, PhD, Merck Research Laboratories, Merck and Co., Inc., West Point, PA
  • Danuta Herzyk, PhD, Merck Research Laboratories, Merck and Co., Inc., West Point, PA

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.
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Audience

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

 

Book information

  • Published: July 2013
  • Imprint: ACADEMIC PRESS
  • ISBN: 978-0-12-394810-6

Reviews

"Researchers in pharmaceuticals, toxicology, and other biological sciences summarize the current status of developing medicines from biological material, pointing out where the process is different from developing small-molecule medicines and where it is the same. The topics include regulatory guidelines and their application in the non-clinical evaluation of biological medicines, early de-risking strategy for novel biotherapeutics…"--Reference & Research Book News, December 2013




Table of 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