Patient-centric Comparability Assessment of Biopharmaceuticals-Reference-Cited by-同舟云学术

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Patient-centric Comparability Assessment of Biopharmaceuticals

Published:2024-06 Issue:6 Volume:113 Page:1415-1425
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Blümel Markus^ORCID,Cordoba-Rodriguez Ruth^ORCID,Carroll James A.^ORCID,Beardsley Richard L.,Maggio Frank,Wylie David,Tsang Valerie^ORCID,Ehrick Robin,Francq Bernard G.,Pohl Thomas^ORCID,Taktak Sonia,Spasoff Andrew,Morrison Amy,Albarghouthi Methal^ORCID

Publisher

Elsevier BV

Reference24 articles.

1. Biological Product Definitions. U.S. Food and Drug Administration. (Accessed 5-JAN 2024). Available from https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf

2. Biosimilar medicines: Overview. EMA Guidance. (Accessed 5-JAN 2024). Available from: https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview

3. ICH Q5E on comparability: ‘Note for guidance on Biotechnological/Biological Products Subject to Changes in their Manufacturing Process’, Step 5, Nov 2004.

4. Patient-centric quality standards;Mire-Sluis;J Pharm Sci,2024

5. EMA Guideline on ‘Comparability of Biotechnology-Derived Medicinal Products after a Change in the Manufacturing Process: Non-Clinical and Clinical Issues’. November 2007. EMEA/CHMP/BMWP/101695/2006.

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