Biosimilar drug product development
by Chow, Shein-Chung Declerck, Paul, (Professor in pharmaceutical sciences) Endrenyi, Laszlo
Title Statements
- Full title :Biosimilar drug product development / edited by Laszlo Endrenyi, University of Toronto, Paul Jules Declerck, KU leuven, Leuven, Belgium, Shein-Chung Chow, Duke University School of Medicine, Durham, USA.
Edition Statements
- Publication Date:©2017
Publication Statements
- Publisher(s):CRC Press, Taylor & Francis Group
- Place of Publication:Boca Raton
- Language:eng
- Publication Date:©2017
The Physical Object
- Description:x, 477 pages, 8 unnumbered pages of plates : : illustrations (some color) ; : 25 cm
Edition Identifiers
- ISBN:9781498718790, 1498718795
- oclc:ocn957634464
- 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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