Impact of Switching on Pharmacokinetics of Therapeutic Biologics and Interchangeability Assessment—A Simulation Study-Reference-Cited by-同舟云学术

Impact of Switching on Pharmacokinetics of Therapeutic Biologics and Interchangeability Assessment—A Simulation Study

Published:2021-10-05 Issue:1 Volume:62 Page:36-45
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharma

Author:

Ji Ping¹,Ren Yupeng¹,Li Liang¹,Schrieber Sarah J.²,Pisal Dipak¹,Hallett William³,Wang Yaning¹,Sahajwalla Chandrahas G.¹

Affiliation:

1. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration Silver Spring Maryland USA

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

3. Office of Biotechnology Products Office of Pharmaceutical Quality Center for Drug Evaluation and Research Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1954

Reference12 articles.

1. HeledY.Biosimilars are a distraction. Health Affairs blog. Published April 8 2019. doi:10.1377/hblog20190328.523018

2. US Food and Drug Administration. Final guidance for industry: considerations in demonstrating interchangeability with a reference product.https://www.fda.gov/media/124907/download. Accessed June 3 2020.

3. A Mathematical Model of the Effect of Immunogenicity on Therapeutic Protein Pharmacokinetics

4. A Model‐Based Approach to Quantify the Time‐Course of Anti‐Drug Antibodies for Therapeutic Proteins

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