Biosimilar Drug Product Development
Author:   Laszlo Endrenyi (University of Toronto, Canada) ,  . Paul Declerck ,  Shein-Chung Chow (Duke Univ, USA)
Publisher:   Taylor & Francis Inc
ISBN:  

9781498718790


Pages:   496
Publication Date:   07 March 2017
Format:   Hardback
Availability:   In Print   Availability explained
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Biosimilar Drug Product Development


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Author:   Laszlo Endrenyi (University of Toronto, Canada) ,  . Paul Declerck ,  Shein-Chung Chow (Duke Univ, USA)
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Weight:   0.904kg
ISBN:  

9781498718790


ISBN 10:   1498718795
Pages:   496
Publication Date:   07 March 2017
Audience:   Professional and scholarly ,  College/higher education ,  Professional & Vocational ,  Tertiary & Higher Education
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

Analytical characterization. Immunogenicity. Animal studies. Clinical development. Manufacturing, process control. Extrapolation of indications. Interchangeability, substitution. Pharmacovigilance. Statistical issues. Regulatory issues.

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Laszlo Endrenyi, Professor Emeritus, University of Toronto

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