{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T16:18:18Z","timestamp":1789402698986,"version":"build-2803163510"},"reference-count":54,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T00:00:00Z","timestamp":1764115200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>The onset of the global COVID\u201019 pandemic created an urgent need for therapeutic monoclonal antibody (mAb) development, while the rapid mutation of the SARS\u2010CoV\u20102 virus and emergence of new variants presented a moving target for validation of efficacy. Since it is virtually impossible to conduct randomized controlled trials in the context of a continually evolving variant landscape, other sources of data can inform ongoing effectiveness and appropriate dosing of existing treatments against new variants. This may include data from in\u00a0vitro neutralization testing, real\u2010world studies, and clinical pharmacology studies. There are various clinical pharmacology approaches available to aid in dose selection of COVID\u201019 mAbs, and the approach used for initial dose selection may differ from that used to justify dose modifications in light of new variants. At present, there is no universally accepted approach that has been shown to work in all circumstances, and most of the available methods lack validation against clinical data. Here, we provide an overview of the different pharmacological approaches available for mAb dose selection or dose adjustments, outlining advantages and limitations of each as well as assumptions, data requirements, and key learnings for each method based on experiences with COVID\u201019 mAb development over the last 4\u2009years. Future mAb development programs for COVID\u201019 or other viral infections with pandemic potential should take into consideration lessons learned from the COVID\u201019 pandemic and devise clinical development programs that generate data to help address new emerging variants of concern in a rapidly evolving virus landscape.<\/jats:p>","DOI":"10.1111\/cts.70421","type":"journal-article","created":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T14:40:06Z","timestamp":1764168006000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Clinical Pharmacology Approaches to Predict Efficacy of Monoclonal Antibodies Against Emerging\n                    <scp>SARS<\/scp>\n                    \u2010\n                    <scp>CoV<\/scp>\n                    \u20102 Variants"],"prefix":"10.1111","volume":"18","author":[{"given":"Qianwen","family":"Wang","sequence":"first","affiliation":[{"name":"GSK, Stevenage  Hertfordshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"Nader","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Modelling and Simulation, GSK  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Peppercorn","sequence":"additional","affiliation":[{"name":"GSK  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Skingsley","sequence":"additional","affiliation":[{"name":"GSK, Brentford  Middlesex UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Lloyd","sequence":"additional","affiliation":[{"name":"GSK, Brentford  Middlesex UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto O.","family":"Stella","sequence":"additional","affiliation":[{"name":"GSK, Brentford  Middlesex UK"},{"name":"UNSW  Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jill","family":"Walker","sequence":"additional","affiliation":[{"name":"GSK  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chad","family":"Garner","sequence":"additional","affiliation":[{"name":"Vir Biotechnology, Inc.  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