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

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

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.


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

Hardbound, 432 Pages

Published: July 2013

Imprint: Academic Press

ISBN: 978-0-12-394810-6


  • "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


  • Preface

    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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