A Model‐Based Approach to Quantify the Time‐Course of Anti‐Drug Antibodies for Therapeutic Proteins-Reference-Cited by-同舟云学术

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

Published:2018-12-09 Issue:4 Volume:105 Page:970-978
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Ren Yupeng¹,Li Liang²,Kirshner Susan³,Wang Yaning²,Sahajwalla Chandrahas¹,Ji Ping¹

Affiliation:

1. Division of Clinical Pharmacology IIOffice of Clinical PharmacologyOffice of Translational SciencesCenter for Drug Evaluation and ResearchFood and Drug Administration Silver Spring Maryland USA

2. Division of PharmacometricsOffice of Clinical PharmacologyOffice of Translational SciencesCenter for Drug Evaluation and ResearchFood and Drug Administration Silver Spring Maryland USA

3. Division of Biotechnology Review and Research IIIOffice of Biotechnology ProductsOffice of Pharmaceutical QualityCenter for Drug Evaluation and ResearchFood and Drug Administration Silver Spring Maryland USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1267

Reference16 articles.

1. Human Insulin from Recombinant DNA Technology

2. Guidance for Industry: Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products. .

3. Immunologic considerations for enzyme replacement therapy in the treatment of lysosomal storage disorders

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

5. Utility of a Bayesian Mathematical Model to Predict the Impact of Immunogenicity on Pharmacokinetics of Therapeutic Proteins

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