A Quantitative Systems Pharmacology Consortium Approach to Managing Immunogenicity of Therapeutic Proteins-Reference-Cited by-同舟云学术

A Quantitative Systems Pharmacology Consortium Approach to Managing Immunogenicity of Therapeutic Proteins

Published:2019-10-08 Issue:11 Volume:8 Page:773-776
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Kierzek Andrzej M.¹,Hickling Timothy P.²^ORCID,Figueroa Isabel³,Kalvass J. Cory³,Nijsen Marjoleen³,Mohan Krithika³,Veldman Geertruida M.³,Yamada Akihiro⁴,Sayama Hiroyuki⁵,Yokoo Sachiko⁵,Gulati Abhishek⁶,Dhanikula Renu S.⁷,Gokemeijer Jochem⁷,Leil Tarek A.⁷,Thalhauser Craig J.⁷,Giorgi Mario¹^ORCID,Swat Maciej J.¹,Chelliah Vijayalakshmi⁸,Small Ben G.¹,Benson Neil⁸,Walker Michael¹,Gadkar Kapil⁹,Quarmby Valerie⁹,Deng Rong⁹,Ferrante Andrea¹⁰,Dickinson Gemma L.¹¹,Van Der Walt Jan‐Stefan¹²,Zhou Lian¹¹,Chen Xiaoying¹³,Jones Hannah M.¹³,Narula Jatin¹³,Tourdot Sophie²,Lavé Thierry¹⁴,Ribba Benjamin¹⁴,Graaf Piet H.⁸^ORCID

Affiliation:

1. Certara QSP Certara UK Limited Sheffield UK

2. BioMedicine Design Pfizer Andover Massachusetts USA

3. AbbVie Inc North Chicago Illinois USA

4. Pharmacometrics JP Clinical Pharmacology and Exploratory Development Astellas Pharma Inc. Tokyo Japan

5. Analysis & Pharmacokinetics Research Labs Astellas Pharma Inc. Tsukuba‐shi Japan

6. Pharmacometrics US, Clinical Pharmacology and Exploratory Development Astellas Pharma Global Development, Inc. Northbrook Illinois USA

7. Bristol‐Myers Squibb Princeton New Jersey USA

8. Certara QSP Certara UK Limited Canterbury UK

9. Development Sciences Genentech San Francisco California USA

10. AME Biotechnology Discovery Research Lilly Biotechnology Center San Diego California USA

11. Eli Lilly and Company Indianapolis Indiana USA

12. Eli Lilly Research & Development Windlesham UK

13. BioMedicine Design Pfizer Cambridge Massachusetts USA

14. Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences Roche Innovation Center Basel Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12465

Reference10 articles.

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

2. Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective

3. A Mechanistic, Multiscale Mathematical Model of Immunogenicity for Therapeutic Proteins: Part 1-Theoretical Model

Cited by 22 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. In silico methods for immunogenicity risk assessment and human homology screening for therapeutic antibodies;mAbs;2024-03-27

2. Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework;The AAPS Journal;2024-03-07

3. Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics;Clinical Pharmacology & Therapeutics;2023-12-18

4. Immunogenicity risk assessment of synthetic peptide drugs and their impurities;Drug Discovery Today;2023-10

5. Model‐Informed Approaches and Innovative Clinical Trial Design for Adeno‐Associated Viral Vector‐Based Gene Therapy Product Development: A White Paper;Clinical Pharmacology & Therapeutics;2023-06-29