자료유형  

 단행본

Control Number  

0013209472

International Standard Book Number  

9782817803357 (alk. paper)

International Standard Book Number  

2817803353 (alk. paper)

International Standard Book Number  

9782817803364 (ebook)

International Standard Book Number  

2817803361 (ebook)

Language Code  

본문언어 - eng, 원저작언어 - fre

Library of Congress Call Number  

RS162-.B5613 2013

Dewey Decimal Classification Number  

615.1-23

Title Statement  

Biosimilars : a new generation of biologics Jean-Louis Prugnaud, Jean-Hugues Trouvin, editors.

Publication, Distribution, etc. (Imprint  

Paris : Springer, 2013.

Physical Description  

xvii, 87 p. : ill. ; 24 cm.

Bibliography, Etc. Note  

Includes bibliographical references.

Formatted Contents Note  

Biologicals’ Characteristics / K. Ho and J.-H. Trouvin -- From the Biosimilar Concept to the Marketing Authorisation / M. Pavlovic and J.-L. Prugnaud -- Immunogenicity / J.-L. Prugnaud -- Substitution and Interchangeability / J.-L. Prugnaud -- G-CSFs: Onco-Hematologist’s Point of View / D. Kamioner -- The Oncologist’s Point of View / C. Chouaïd -- Biosimilars: Challenges Raised by Biosimilars: Who is Responsible for Cost and Risk Management? / F. Megerlin.

Subject Added Entry-Topical Term  

Biologicals

Subject Added Entry-Topical Term  

Biosimilar Pharmaceuticals

Added Entry-Personal Name  

Prugnaud, Jean-Louis.

Added Entry-Personal Name  

Trouvin, Jean-Hugues.

Added Entry-Uniform Title  

Biosimilaires.. English

Control Number  

ydul:92584

책소개  

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.