Nonclinical development of novel biologics, biosimilars, vaccines and specialty biologics / edited by Lisa M. Plitnick, MS, PhD, and Danuta J. Herzyk, PhD, Merck Research Laboratories, Merck & Co., Inc. West Point, PA, USA.

Format:

Book

Contributor:

Plitnick, Lisa M., editor.

Herzyk, Danuta J., editor.

Series:

Gale eBooks

Language:

English

Subjects (All):

Biopharmaceutics.

Biologicals.

Biological products.

Physical Description:

1 online resource (xv, 416 pages, 8 unnumbered pages of plates) : illustrations (some color)

Place of Publication:

London : Academic Press, 2013.

Language Note:

English

Summary:

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 pha

Contents:

Front Cover; Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics; Copyright; Dedication; Contents; 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 MedicinesINTRODUCTION; 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 IMMUNOTOXICITYCAN 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 ASSAYSSUMMARY; References; Section II Development of Biosimilars; Chapter 5 - Overview of Biosimilar Therapeutics; INTRODUCTION; THE CONCEPT OF BIOSIMILARS; GENERAL CONSIDERATIONS FOR DEVELOPMENT OF BIOSIMILARS; BIOSIMILAR CANDIDATES BASED ON MODALITY AND THERAPEUTIC CLASS; SUMMARY; References; Chapter 6 - Regulatory Standards for the Approval of Biosimilar Products: A Global Review; INTRODUCTION; EUROPEAN UNION-PIONEER FOR THE FIRST REGULATORY PATHWAY FOR BIOSIMILAR PRODUCTS; THE WORLD HEALTH ORGANIZATION GUIDANCE ON BIOSIMILARS

REGULATORY PATHWAY FOR BIOSIMILAR PRODUCTS IN THE UNITED STATESBIOSIMILAR PATHWAYS IN OTHER REGIONS; SUMMARY; References; Chapter 7 - Early Characterization of Biosimilar Therapeutics; INTRODUCTION; RECOMBINANT INSULINS; RECOMBINANT HUMAN GROWTH HORMONE; RECOMBINANT ERYTHROPOIETINS; RECOMBINANT GRANULOCYTE COLONY-STIMULATING FACTOR; RECOMBINANT INTERFERONS; LOW MOLECULAR WEIGHT HEPARINS; MONOCLONAL ANTIBODIES; OTHER CLASSES; SUMMARY; References; Section III Vaccines; Chapter 8 - Introduction to Vaccines and Adjuvants; INTRODUCTION; THE HISTORY OF VACCINES

THE IMPACT OF VACCINES ON HUMAN HEALTH

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

ISBN:

9780123948236

0123948231

OCLC:

860713555