Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics, 1st Edition

  • Published By:
  • ISBN-10: 0123948231
  • ISBN-13: 9780123948236
  • DDC: 615.7
  • Grade Level Range: College Freshman - College Senior
  • 432 Pages | eBook
  • Original Copyright 2013 | Published/Released June 2014
  • This publication's content originally published in print form: 2013

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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.

Table of Contents

Front Cover.
Half Title Page.
Title Page.
Copyright Page.
Table of Contents.
1: Development of Biopharmaceuticals Defined as Novel Biologics.
2: Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development.
3: Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological Medicines.
4: Early De-risking Strategy for Novel Biotherapeutics.
5: Novel Biopharmaceuticals: Pharmacokinetics, Pharmacodynamics, and Bioanalytics.
6: Development of Biosimilars.
7: Overview of Biosimilar Therapeutics.
8: Regulatory Standards for the Approval of Biosimilar Products: A Global Review.
9: Early Characterization of Biosimilar Therapeutics.
10: Vaccines.
11: Introduction to Vaccines and Adjuvants.
12: Global Regulatory Guidelines for Vaccines.
13: Special Considerations for the Nonclinical Safety Assessment of Vaccines.
14: Specialty Biologics and Indications.
15: Turning the Corner with Viral-based Gene Therapy—Development of the Rogue Biopharmaceutical.
16: Blood Products.
17: Biological Therapies for Cancer.
18: Nonclinical Development of Multi-targeting Biopharmaceuticals.
19: Considerations in the Development of Pluripotent Stem Cell-based Therapies.
Color Plates.