Model‐Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development-Reference-Cited by-同舟云学术

Model‐Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development

Published:2022-08-24 Issue:1 Volume:113 Page:62-70
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Li Fang¹,Sun Qin¹,Du Shengnan¹,Florian Jeffry¹,Wang Yaning¹,Huang Shiew Mei¹^ORCID,Zineh Issam¹,Wang Yow‐Ming C.¹^ORCID

Affiliation:

1. 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.2722

Reference20 articles.

1. U.S. Food and Drug Administration.Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. (2015).

2. U.S. Food and Drug Administration.Guidance for industry: clinical pharmacology data to support a demonstration of biosimilarity to a reference product. (2016).

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

4. Dynamics of target-mediated drug disposition: characteristic profiles and parameter identification

5. Application of Pharmacometric Analysis in the Design of Clinical Pharmacology Studies for Biosimilar Development

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