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

dc.contributor.authorShakhnovich, Valentina
dc.contributor.authorMeibohm, Bernd
dc.contributor.authorRosenberg, Amy
dc.contributor.authorKierzek, Andrzej M.
dc.contributor.authorHasenkamp, Rachel
dc.contributor.authorFunk, Ryan S.
dc.contributor.authorThalhauser, Craig J.
dc.contributor.authorvan der Graaf, Piet H.
dc.contributor.authorWang, Yow-Ming C.
dc.contributor.authorHamuro, Lora
dc.date.accessioned2022-09-08T19:05:38Z
dc.date.available2022-09-08T19:05:38Z
dc.date.issued2019-11-25
dc.identifier.citationShakhnovich, 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.12717en_US
dc.identifier.urihttp://hdl.handle.net/1808/33440
dc.description.abstractManaging 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.en_US
dc.publisherWiley Open Accessen_US
dc.rights© 2019 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License.en_US
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/en_US
dc.titleImmunogenicity in Clinical Practice and Drug Development: When is it Significant?en_US
dc.typeArticleen_US
kusw.kuauthorFunk, Ryan S.
kusw.kudepartmentPharmacy Practiceen_US
kusw.oanotesPer Sherpa Romeo 09/08/2022:

Clinical and Translational Science [Open panel below]Publication Information TitleClinical and Translational Science (CTS) [English] ISSNs Print: 1752-8054 Electronic: 1752-8062 URLhttps://ascpt.onlinelibrary.wiley.com/journal/17528062 Publishers Wiley Open Access [Commercial Publisher] Wiley Periodicals [Associate Organisation] DOAJ Listinghttps://doaj.org/toc/1752-8054 Requires APCYes [Data provided by DOAJ] [Open panel below]Publisher Policy Open Access pathways permitted by this journal's policy are listed below by article version. Click on a pathway for a more detailed view.

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NoneCC BY-NCPMC Any Website, Journal Website, +3 OA PublishingThis pathway includes Open Access publishing EmbargoNo Embargo Licence CC BY-NC CC BY-NC-ND CC BY-ND Copyright OwnerAuthors Publisher DepositPubMed Central Location Any Website Institutional Repository Named Repository (PubMed Central) Subject Repository Journal Website Conditions Published source must be acknowledged Hosting site must incorporate publisher-supplied amendments or retractions issued Must link to published version with DOI		en_US
dc.identifier.doi10.1111/cts.12717en_US
kusw.oaversionScholarly/refereed, publisher versionen_US
kusw.oapolicyThis item meets KU Open Access policy criteria.en_US
kusw.proidID210131431424en_US
dc.rights.accessrightsopenAccessen_US


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© 2019 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License.
Except where otherwise noted, this item's license is described as: © 2019 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License.