Stability and biosimilarity assessment of infliximab using an orthogonal testing protocol and statistically-guided interpretation of peptide mapping
Author:
Affiliation:
1. National Organization for Research and Control of Biologicals
2. Egypt
3. Analytical Chemistry Department
4. Faculty of Pharmacy
5. Cairo University
6. Cairo 11562
Abstract
With the growing number of biosimilars, healthcare providers opt to switch costly originator products with biosimilars.
Publisher
Royal Society of Chemistry (RSC)
Subject
General Engineering,General Chemical Engineering,Analytical Chemistry
Link
http://pubs.rsc.org/en/content/articlepdf/2019/AY/C9AY00903E
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5. S. K. Niazi , Biosimilarity: The FDA Perspective , CRC Press , 2018
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