Biosimilars (Record no. 96246)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04356nam a22005175i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 978-2-8178-0336-4 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20140220082835.0 |
| 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 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-2-8178-0336-4 |
| Source of number or code | doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RC254-282 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MJCL |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED062000 |
| Source | bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 616.994 |
| Edition number | 23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Prugnaud, Jean-Louis. |
| Relator term | editor. |
| 245 10 - TITLE STATEMENT | |
| 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. |
| 264 #1 - | |
| -- | Paris : |
| -- | Springer Paris : |
| -- | Imprint: Springer, |
| -- | 2013. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | XVII, 87 p. 7 illus., 5 illus. in color. |
| Other physical details | online resource. |
| 336 ## - | |
| -- | text |
| -- | txt |
| -- | rdacontent |
| 337 ## - | |
| -- | computer |
| -- | c |
| -- | rdamedia |
| 338 ## - | |
| -- | online resource |
| -- | cr |
| -- | rdacarrier |
| 347 ## - | |
| -- | text file |
| -- | |
| -- | rda |
| 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. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Immunology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical technology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacy. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Nephrology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Oncology. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medicine & Public Health. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Oncology. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Nephrology. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacy. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical Sciences/Technology. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 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 |
| 912 ## - | |
| -- | ZDB-2-SME |
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