{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T17:10:11Z","timestamp":1780333811229,"version":"3.54.1"},"reference-count":16,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,9,5]],"date-time":"2023-09-05T00:00:00Z","timestamp":1693872000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:p>Nirmatrelvir is a potent and selective severe acute respiratory syndrome\u2010coronavirus 2 (SARS\u2010CoV\u20102) main protease inhibitor. Nirmatrelvir co\u2010packaged with ritonavir (as PAXLOVID) received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) on December 22, 2021, as an oral treatment for coronavirus disease 2019 (COVID\u201019) and subsequent new drug application approval on May 25, 2023. Pharmacokinetic (PK) capillary blood sampling at\u2010home using Tasso\u2010M20 micro\u2010volumetric sampling device was implemented in the program, including three phase II\/III outpatient and several clinical pharmacology studies supporting the EUA. The at\u2010home sampling complemented venous blood sampling procedures to enrich the PK dataset, to decrease the need for patients' site visit for PK sampling, and to allow different sampling approaches for flexibility and convenience. To demonstrate concordance\/equivalence, bridging between venous plasma and Tasso dried blood results was conducted by comparing concentrations and derived PK parameters from both sampling approaches. In addition, a two\u2010compartment population PK model was utilized to bridge the plasma and Tasso data by estimating the PK parameters using blood\u2010to\u2010plasma ratio as a slope parameter. Operational challenges were successfully managed to implement at\u2010home PK sampling in global phase II\/III trials. Sample quality was generally very good with less than 3% samples deemed as \u201cnot usable\u201d from over 800 samples collected in all the studies. Experience gained from sites and patients will guide future broader implementations.<\/jats:p>","DOI":"10.1002\/cpt.3025","type":"journal-article","created":{"date-parts":[[2023,8,19]],"date-time":"2023-08-19T17:37:23Z","timestamp":1692466643000},"page":"42-51","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation"],"prefix":"10.1002","volume":"115","author":[{"given":"Katty","family":"Wan","sequence":"first","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Kavetska","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4615-0122","authenticated-orcid":false,"given":"Bharat","family":"Damle","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haihong","family":"Shi","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4650-2877","authenticated-orcid":false,"given":"Donna S.","family":"Cox","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olayide","family":"Oladoyinbo","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phylinda","family":"Chan","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6298-8219","authenticated-orcid":false,"given":"Ravi Shankar P.","family":"Singh","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Craft","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erwin","family":"Berthier","sequence":"additional","affiliation":[{"name":"Tasso Inc  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-0166-7076","authenticated-orcid":false,"given":"Brian","family":"Corrigan","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,9,5]]},"reference":[{"key":"e_1_2_12_1_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.1085658"},{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.abl4784"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2603"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.4155\/bio-2021-0120"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-020-01144-1"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.4155\/bio-2020-0105"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13411"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.4155\/bio-2019-0041"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1021\/ac5022562"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-020-00524-2"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.11613\/BM.2015.015"},{"key":"e_1_2_12_12_1","volume-title":"Bioanalytical Method Validation Guidance on Industry","author":"US Department of Health and Human Serives; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Veterinary Medicine (CVM)","year":"2018"},{"key":"e_1_2_12_13_1","volume-title":"Guideline on Bioanalytical Method Validation","author":"European Medicines Agency","year":"2012"},{"key":"e_1_2_12_14_1","unstructured":"Chan P.et al.Population pharmacokinetics of nirmatrelvir\/ritonavir in healthy participants and adults with COVID\u201019 to support dosing in renally insufficiency and paediatric (12 to <18\u2009years) populations. Parmacokinetics UK 2022<http:\/\/www.pkuk.org.uk\/ContentImages\/PKUK_2022_Progandabstractbooklet\u2010F2.pdf>."},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.4155\/bio-2022-0167"},{"key":"e_1_2_12_16_1","unstructured":"TASSO\u2010M20 Training Video\u2014Tasso Inc. <https:\/\/www.tassoinc.com\/tasso\u2010m20\u2010video>."}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.3025","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,12,31]],"date-time":"2023-12-31T05:43:39Z","timestamp":1704001419000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.3025"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,5]]},"references-count":16,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,1]]}},"alternative-id":["10.1002\/cpt.3025"],"URL":"https:\/\/doi.org\/10.1002\/cpt.3025","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,5]]},"assertion":[{"value":"2023-05-25","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-07","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-09-05","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}