Cargando…

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...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Plitnick, Lisa M. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London, UK : Elsevier, AP, Academic Press is an imprint of Elsevier, [2013]
Temas:
Acceso en línea:Texto completo

MARC

LEADER 00000cam a2200000Mi 4500
001 EBOOKCENTRAL_ocn875692444
003 OCoLC
005 20240329122006.0
006 m o d
007 cr |n|||||||||
008 140102s2013 enka o 000 0 eng d
010 |a  2012276020 
040 |a CGU  |b eng  |e pn  |c CGU  |d OCLCO  |d UKDOC  |d OCLCQ  |d OCLCF  |d YDXCP  |d EBLCP  |d COO  |d OCLCQ  |d AU@  |d OCLCO  |d WYU  |d OCLCA  |d OCLCQ  |d VT2  |d OCLCO  |d OCLCQ  |d OCL  |d OCLCO  |d OCLCA  |d OCLCL 
015 |a GBB358839  |2 bnb 
016 7 |a 016448231  |2 Uk 
019 |a 854520312  |a 858096918  |a 1065919607  |a 1235846403 
020 |a 9780123948236  |q (electronic bk.) 
020 |a 0123948231  |q (electronic bk.) 
020 |a 012394810X  |q (Trade Cloth) 
020 |a 9780123948106  |q (Trade Cloth) 
020 |z 9780123948106 
029 1 |a AU@  |b 000058153161 
035 |a (OCoLC)875692444  |z (OCoLC)854520312  |z (OCoLC)858096918  |z (OCoLC)1065919607  |z (OCoLC)1235846403 
037 |b 00991439 
050 4 |a RM301.4  |b .N66 2013 
082 0 4 |a 615.7  |2 23 
049 |a UAMI 
245 0 0 |a Nonclinical development of novel biologics, biosimilars, vaccines and specialty biologics /  |c edited by Lisa M. Plitnick, MS, PhD and Danuta J. Herzyk, PhD, Merck Research Laboratories, Merck & Co., Inc. West Point, PA, USA. 
264 1 |a London, UK :  |b Elsevier, AP, Academic Press is an imprint of Elsevier,  |c [2013] 
300 |a 1 online resource 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
588 0 |a Print version record. 
505 0 |a 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. 
505 8 |a 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. 
505 8 |a 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. 
505 8 |a 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. 
505 8 |a 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. 
520 |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. 
504 |a Includes bibliographical references and index. 
590 |a ProQuest Ebook Central  |b Ebook Central Academic Complete 
650 0 |a Biopharmaceutics. 
650 0 |a Pharmacology. 
650 0 |a Medical personnel. 
650 0 |a Life sciences. 
650 0 |a Physical sciences. 
650 0 |a Biologicals. 
650 2 |a Complex Mixtures 
650 2 |a Pharmacology 
650 2 |a Chemicals and Drugs. 
650 2 |a Health Occupations 
650 2 |a Biological Science Disciplines 
650 2 |a Disciplines and Occupations. 
650 2 |a Natural Science Disciplines 
650 2 |a Biopharmaceutics 
650 2 |a Biological Products 
650 2 |a Health Workforce. 
650 2 |a Health Personnel 
650 6 |a Biopharmacie. 
650 6 |a Pharmacologie. 
650 6 |a Personnel médical. 
650 6 |a Sciences de la vie. 
650 6 |a Sciences physiques. 
650 6 |a Médicaments biologiques. 
650 7 |a pharmacology.  |2 aat 
650 7 |a biological sciences.  |2 aat 
650 7 |a physical sciences.  |2 aat 
650 7 |a Physical sciences  |2 fast 
650 7 |a Pharmacology  |2 fast 
650 7 |a Medical personnel  |2 fast 
650 7 |a Life sciences  |2 fast 
650 7 |a Biopharmaceutics  |2 fast 
650 7 |a Health & Biological Sciences.  |2 hilcc 
650 7 |a Pharmacy, Therapeutics, & Pharmacology.  |2 hilcc 
700 1 |a Plitnick, Lisa M.,  |e editor. 
758 |i has work:  |a Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics (Text)  |1 https://id.oclc.org/worldcat/entity/E39PCXtmrGhxGbG3PyhJPpQJqj  |4 https://id.oclc.org/worldcat/ontology/hasWork 
776 0 8 |i Print version:  |t Nonclinical development of novel biologics, biosimilars, vaccines and specialty biologics.  |z 9780123948106 
856 4 0 |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=1239241  |z Texto completo 
938 |a 123Library  |b 123L  |n 102608 
938 |a ProQuest Ebook Central  |b EBLB  |n EBL1239241 
938 |a YBP Library Services  |b YANK  |n 10832731 
994 |a 92  |b IZTAP