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Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Shakhnovich, Valentina
; 
Meibohm, Bernd
; 
Rosenberg, Amy
; 
Kierzek, Andrzej M.
; 
Hasenkamp, Rachel
; 
Funk, Ryan S.
; 
Thalhauser, Craig J.
; 
van der Graaf, Piet H.
; 
Wang, Yow-Ming C.
; 
Hamuro, Lora
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Abstract
Managing immunogenicity in clinical practice and during drug development was a recent topic at the ASCPT 2019 annual meeting. This commentary expands on the discussion to facilitate a broader engagement across the community. The intent is to provide a rationale for ongoing research into the current gaps in assessing and interpreting immunogenicity in drug development and managing clinical immunogenicity for an approved drug. The following are highlighted: (i) Immunogenicity Considerations in Clinical Practice, (ii) Immunogenicity Testing and Current Limitations, (iii) Immunogenicity Risk Assessment and Mitigation, and (iv) Quantitative Systems Pharmacology (QSP) models of Immunogenicity.
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Date
2019-11-25
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Wiley Open Access
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Pharmacy Scholarly Works
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Shakhnovich_2020.pdf
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Shakhnovich, V., Meibohm, B., Rosenberg, A., Kierzek, A.M., Hasenkamp, R., Funk, R.S., Thalhauser, C.J., van der Graaf, P.H., Wang, Y.-M.C. and Hamuro, L. (2020), Immunogenicity in Clinical Practice and Drug Development: When is it Significant?. Clin Transl Sci, 13: 219-223. https://doi.org/10.1111/cts.12717
URI
https://hdl.handle.net/1808/33440
DOI
10.1111/cts.12717
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