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

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

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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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Product details

  • Hardback | 432 pages
  • 195.58 x 238.76 x 27.94mm | 1,088.62g
  • Academic Press Inc
  • San Diego, United States
  • English
  • Illustrated; Illustrations, unspecified
  • 012394810X
  • 9780123948106
  • 2,114,587

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
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Review quote

"...brings nonclinical testing of biological and follow-on biological drugs, vaccines plus cell and gene therapy drugs right up to date. It is written in a very readable, yet highly scientific manner and most of the relevant publications...on the topic are referenced...Overall, a `must read' book for all in the nonclinical field of developing biological drugs."--btsNews, June 2014 "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
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