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Biosimilars (Record no. 20141)

000 -LEADER
fixed length control field 04268nam a22004935i 4500
003 - CONTROL NUMBER IDENTIFIER
control field OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20140310150652.0
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr nn 008mamaa
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 121120s2013 fr | s |||| 0|eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9782817803364
978-2-8178-0336-4
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RC254-282
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 616.994
Edition number 23
264 #1 -
-- Paris :
-- Springer Paris :
-- Imprint: Springer,
-- 2013.
912 ## -
-- ZDB-2-SME
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Prugnaud, Jean-Louis.
Relator term editor.
245 10 - IMMEDIATE SOURCE OF ACQUISITION NOTE
Title Biosimilars
Medium [electronic resource] :
Remainder of title A New Generation of Biologics /
Statement of responsibility, etc edited by Jean-Louis Prugnaud, Jean-Hugues Trouvin.
300 ## - PHYSICAL DESCRIPTION
Extent XVII, 87 p. 7 illus., 5 illus. in color.
Other physical details online resource.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Preface: Biosimilars – a philosophy? -- Foreword -- 1. Biosimilars characteristics -- Introduction : from generics to biosimilars -- Definitions -- Complexity of biologics and examples -- Conclusion -- 2. From the biosimilar concept to the Marketing Approval. –Introduction -- Definition of biosimilars -- Pharmaceutical approval’s framework -- Quality control approach -- Non clinical and clinical aspects -- Recommendations in onco-hematology -- Other recommendations -- Conclusion -- 3. Immunogenicity -- Introduction -- Immune mechanisms -- Usual immune response -- Immunologic tolerance breakdown response -- Factors influencing immunogenicity -- Case of monoclonal antibodies -- Conclusion -- 4. Substitution and interchangeability -- Introduction -- Generics and biosimilars’ substitution -- What about biosimilar medicinal  products ? -- Interchangeability: suggested definition -- Biosimilars’ interchangeability and conditions to be implemented -- Interchangeability practices -- Conclusion -- 5. Onco-hematologist point of view –GCSFcase -- Biosimilars -- Conclusion -- 6. The oncologist‘s point of view -- Introduction -- Erythropoiesis-stimulating Agents (ESA) -- Biosimilars -- Conclusion -- 7. Challenges posed by biosimilars: who is responsible for cost and risk management -- Introduction -- General information on cost management -- Savings linked to the purchase of biosimilars -- General information on risk management responsibility -- Conclusion.
520 ## - SUMMARY, ETC.
Summary, etc Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities.   In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature.   This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Medicine.
Topical term or geographic name as entry element Immunology.
Topical term or geographic name as entry element Pharmaceutical technology.
Topical term or geographic name as entry element Pharmacy.
Topical term or geographic name as entry element Nephrology.
Topical term or geographic name as entry element Oncology.
Topical term or geographic name as entry element Medicine & Public Health.
Topical term or geographic name as entry element Oncology.
Topical term or geographic name as entry element Nephrology.
Topical term or geographic name as entry element Pharmacy.
Topical term or geographic name as entry element Pharmaceutical Sciences/Technology.
Topical term or geographic name as entry element Immunology.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Trouvin, Jean-Hugues.
Relator term editor.
710 2# - ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element SpringerLink (Online service)
773 0# - HOST ITEM ENTRY
Title Springer eBooks
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Display text Printed edition:
International Standard Book Number 9782817803357
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier http://dx.doi.org/10.1007/978-2-8178-0336-4
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme
Item type E-Book
Copies
Price effective from Permanent location Date last seen Not for loan Date acquired Source of classification or shelving scheme Koha item type Damaged status Lost status Withdrawn status Current location Full call number
2014-04-07AUM Main Library2014-04-07 2014-04-07 E-Book   AUM Main Library616.994