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Description
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.
Key Features
- Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical
- Contains the most pertinent international regulatory guidance documents for nonclinical evaluation
- Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars"
- A multi-authored book with chapters written by qualified experts in their respective fields
Readership
Pharmaceutical scientists, toxicologists, geneticists, biochemists, cell biologists and immunologists working in the area of biologics within academia, small biotechnology and large pharmaceutical companies.
Table of Contents
Dedication
Preface
Contributors
Acknowledgments
Section I: Development of Biopharmaceuticals Defined as Novel Biologics
Chapter 1. Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development
Introduction
History and Evolution of Biopharmaceuticals
Development of Diverse Biopharmaceutical Modalities
Comparison of Small-Molecule Drugs to Biopharmaceuticals
Summary
References
Chapter 2. Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological Medicines
Introduction
Species Selection
Study Design Considerations for Repeat-Dose Studies
Immunogenicity
Reproductive and Developmental Toxicity
Genotoxicity and Carcinogenicity
Special Considerations for Anticancer Drugs
First-in-Human (Fih) Clinical Trial
Summary
References
Chapter 3. Early De-risking Strategy for Novel Biotherapeutics
Introduction
Establishing A Safety Profile for Biotherapeutics
General Safety Considerations Related to Biotherapeutics
Progress in Evaluation of Immunotoxicity
Can We Better Address Potential Off-Target Toxicity?
Summary
References
Chapter 4. Novel Biopharmaceuticals: Pharmacokinetics, Pharmacodynamics, and Bioanalytics
Introduction
Absorption, Distribution and Elimination of Biopharmaceuticals
Disposition of Modified Molecules
“Metabolism” and Biodistribution for Biopharmaceuticals
Immunogenicity and impacts on PK and biodistribution
Pharmacokinetics and Pharmacodynamics
Preclinical to Clinical Translation
Bioanalytics
Drug Assays
Biomarkers: Target Engagement Assays
Immunogenicity Assessment: ADA Assays
Summary
References
Section II: Development of Biosimilars
Ch
Details
- No. of pages:
- 432
- Language:
- English
- Copyright:
- © 2013
- Published:
- 19th July 2013
- Imprint:
- Academic Press
- eBook ISBN:
- 9780123948236
- Print ISBN:
- 9780123948106
About the editors
Lisa Plitnick
Affiliations and Expertise
PhD, Merck Research Laboratories, Merck and Co., Inc., West Point, PA
Danuta Herzyk
Affiliations and Expertise
PhD, Merck Research Laboratories, Merck and Co., Inc., West Point, PA
Reviews
"…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