Biosimilar drug product development

Biosimilar drug product development

by Chow, Shein-Chung Declerck, Paul Jules Endrenyi, Laszlo

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Title Statements

  • Full title :Biosimilar drug product development / edited by Laszlo Endrenyi, Paul jules Declerck, Shein-Chung Chow.

Edition Statements

  • Publication Date:C 2017

Publication Statements

  • Publisher(s):CRC Press
  • Place of Publication:Boca Raton
  • Language:eng
  • Publication Date:C 2017

The Physical Object

  • Description:1 v. (X-477 p.) : : illustrations, couv. illustrations en coul. ; : 24 cm

Edition Identifiers

  • ISBN:9781498718790, 1498718795
  • oclc:ocn991882172
  • LC Classification:RM301.25
  • Dewey Decimal:615.1/9

Table of Contents

Introduction : scientific factors in biosimilar drug product development / Laszlo Endrenyi, Paul Declerck, Shein-Chung Chow -- Analytical characterization : structural assessment of biosimilarity / Steven Berkowitz -- Analytical similarity assessment / Shein-Chung Chow, Li Liu -- Characterization of biosimilar biologics : the link between structure and functions / Roy Jefferis -- Manufacturing and process control issues -- quality development of biosimilar medicinal products / Alan Fauconnier, Lyudmil Antonov -- Animal studies / Karen de Smet, Leon van Aerts -- The clinical development of biosimilar drugs / Mark McCamish, Gillian R. Woollett, Sigrid Balser -- Statistical methods for biosimilarity / Shein-Chung Chow, Fuyu Song -- Extrapolation of indications / Jian Wang, Wallace Lauzon, Catherine Njue, Agnes V. Klein -- Interchangeability, switchability and substitution of biosimilars / Paul Declerck, Laszlo Endrenyi, Shein-Chung Chow -- Design and analysis of studies for assessing interchangeability / Shein-Chung Chow, Laszlo Endrenyi -- Role of immunogenicity evaluation for biosimilars / Paul Chamberlain -- Pharmacovigilance of biosimilars / Shehla Hashim, Souleh Semalulu, Felix …

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Subjects

Biosimilaires Biosimilar Pharmaceuticals Biosimilar Pharmaceuticals (MeSH - aucu… Drug Approval Drug Approval (MeSH - aucune traduction) Drug Evaluation Drug Evaluation (MeSH - aucune traducti… Médicaments -- Mise au point Médicaments biosimilaires

Writers

Chow, Shein-Chung Declerck, Paul Jules Endrenyi, Laszlo

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