Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments-Reference-Cited by-同舟云学术

Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments

Published:2020-09-28 Issue:3 Volume:109 Page:697-704
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Guinn Daphne¹,Madabushi Rajanikanth¹,Wang Yow‐Ming¹,Zineh Issam¹,Maxfield Kimberly¹

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.2038

Reference13 articles.

1. US Food and Drug Administration. Guidance for Industry.Immunogenicity Assessment for Therapeutic Protein Products Guidance for Industry (2014).

2. US Food and Drug Administration.Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti‐Drug Antibody Detection Guidance for Industry (2019).

3. Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

4. Postmarketing reporting of adverse drug experiences 21 CFR 314.80. (2011).

5. US Food and Drug Administration.Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food Drug and Cosmetic Act Guidance for Industry (2019).

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