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Two\u2010stage population pharmacokinetic (PK) modeling of letermovir was conducted to support dose rationale and evaluate the impact of intrinsic\/extrinsic factors. Data from healthy phase I study participants over a wide dose range were modeled to evaluate the effects of selected intrinsic factors, including pharmacogenomics; next, phase III HSCT\u2010recipient data at steady\u2010state following clinical doses were modeled. The model in HSCT recipients adequately described letermovir PK following both oral or i.v. administration, and was consistent with the healthy participant model at steady\u2010state clinical doses. Intrinsic factor effects were not clinically meaningful. These staged analyses indicate that letermovir PK in HSCT recipients and healthy participants differ only with respect to bioavailability and absorption rate. The HSCT recipient model was suitable for predicting exposure for exposure\u2013response analysis supporting final dose selection.<\/jats:p>","DOI":"10.1002\/psp4.12593","type":"journal-article","created":{"date-parts":[[2021,1,15]],"date-time":"2021-01-15T15:10:16Z","timestamp":1610723416000},"page":"255-267","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Population pharmacokinetics of letermovir following oral and intravenous administration in healthy participants and allogeneic hematopoietic cell transplantation recipients"],"prefix":"10.1002","volume":"10","author":[{"given":"Marita","family":"Prohn","sequence":"first","affiliation":[{"name":"qPharmetra Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anders","family":"Viberg","sequence":"additional","affiliation":[{"name":"qPharmetra Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Da","family":"Zhang","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc. 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