LEADER 05124oam 2200541 450 001 9910779753803321 005 20170523091546.0 010 $a0-12-394823-1 035 $a(OCoLC)860713555 035 $a(MiFhGG)GVRL6ZKV 035 $a(EXLCZ)992550000001095152 100 $a20131216d2013 uy 0 101 0 $aeng 135 $aurun|---uuuua 181 $ctxt 182 $cc 183 $acr 200 00$aNonclinical development of novel biologics, biosimilars, vaccines and specialty biologics /$fedited by Lisa M. Plitnick, MS, PhD, and Danuta J. Herzyk, PhD, Merck Research Laboratories, Merck & Co., Inc. West Point, PA, USA 210 $aLondon $cAcademic Press$d2013 210 1$aLondon :$cAcademic Press,$d2013. 215 $a1 online resource (xv, 416 pages, 8 unnumbered pages of plates) $cillustrations (some color) 225 0 $aGale eBooks 300 $aDescription based upon print version of record. 311 $a0-12-394810-X 311 $a1-299-70889-7 320 $aIncludes bibliographical references and index. 327 $aFront 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 327 $aChapter 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 327 $aPROGRESS 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 327 $aIMMUNOGENICITY 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 327 $aREGULATORY 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 327 $aTHE IMPACT OF VACCINES ON HUMAN HEALTH 330 $a 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 606 $aBiopharmaceutics 606 $aBiologicals 606 $aBiological products 615 0$aBiopharmaceutics. 615 0$aBiologicals. 615 0$aBiological products. 676 $a615/.19 702 $aPlitnick$b Lisa M. 702 $aHerzyk$b Danuta J. 801 0$bMiFhGG 801 1$bMiFhGG 906 $aBOOK 912 $a9910779753803321 996 $aNonclinical development of novel biologics, biosimilars, vaccines and specialty biologics$93844533 997 $aUNINA