Immunogenicity in Clinical Practice and Drug Development: When is it Significant?
dc.contributor.author | Shakhnovich, Valentina | |
dc.contributor.author | Meibohm, Bernd | |
dc.contributor.author | Rosenberg, Amy | |
dc.contributor.author | Kierzek, Andrzej M. | |
dc.contributor.author | Hasenkamp, Rachel | |
dc.contributor.author | Funk, Ryan S. | |
dc.contributor.author | Thalhauser, Craig J. | |
dc.contributor.author | van der Graaf, Piet H. | |
dc.contributor.author | Wang, Yow-Ming C. | |
dc.contributor.author | Hamuro, Lora | |
dc.date.accessioned | 2022-09-08T19:05:38Z | |
dc.date.available | 2022-09-08T19:05:38Z | |
dc.date.issued | 2019-11-25 | |
dc.identifier.citation | 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 | en_US |
dc.identifier.uri | http://hdl.handle.net/1808/33440 | |
dc.description.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. | en_US |
dc.publisher | Wiley Open Access | en_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.uri | http://creativecommons.org/licenses/by-nc/4.0/ | en_US |
dc.title | Immunogenicity in Clinical Practice and Drug Development: When is it Significant? | en_US |
dc.type | Article | en_US |
kusw.kuauthor | Funk, Ryan S. | |
kusw.kudepartment | Pharmacy Practice | en_US |
dc.identifier.doi | 10.1111/cts.12717 | en_US |
kusw.oaversion | Scholarly/refereed, publisher version | en_US |
kusw.oapolicy | This item meets KU Open Access policy criteria. | en_US |
dc.rights.accessrights | openAccess | en_US |
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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.