Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval-Reference-Cited by-同舟云学术

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

Published:2022-11-02 Issue:1 Volume:113 Page:55-61
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Strauss David G.¹^ORCID,Wang Yow‐Ming²^ORCID,Florian Jeffry¹,Zineh Issam³

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 Program, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

3. Immediate Office, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2761

Reference16 articles.

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

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

3. Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G-CSF in Breast Cancer Patients

4. US Food and Drug Administration.FDA draft guidance: Biomarker Qualification: Evidentiary Framework (2018). Accessed April 1 2022.

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

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