Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ ‐1a Biologics

Author:

Hyland Paula L.1,Chekka Lakshmi Manasa S.1,Samarth Deepti P.1,Rosenzweig Barry A.1,Decker Erica1ORCID,Mohamed Esraa G.1,Guo Yan1,Matta Murali K.1ORCID,Sun Qin2,Wheeler William3,Sanabria Carlos4,Weaver James L.1ORCID,Schrieber Sarah J.5,Florian Jeffry1,Wang Yow‐Ming2ORCID,Strauss David G.1ORCID

Affiliation:

1. Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA

2. Therapeutic Biologics Protein Team, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA

3. Information Management Services, Inc. Rockville Maryland USA

4. Spaulding Clinical Research West Bend Wisconsin USA

5. Office of Therapeutic Biologics and Biosimilars, Office of New Drugs Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference41 articles.

1. US Food and Drug Administration.FDA Guidance: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product(2015). Accessed 1 May 2022.

2. Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

3. Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions

4. US Food and Drug Administration.FDA Guidance: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product(2016). Accessed 1 May 2022.

5. “Omics”-Informed Drug and Biomarker Discovery: Opportunities, Challenges and Future Perspectives

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