{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T01:41:47Z","timestamp":1747186907107,"version":"3.40.5"},"reference-count":11,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,12,8]],"date-time":"2020-12-08T00:00:00Z","timestamp":1607385600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Vet Pharm &amp; Therapeutics"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Product blood\u2010level in vivo bioequivalence (BE) studies typically involve complete blood concentration\u2013time profiles generated for each subject. Accordingly, each subject provides the estimates of the rate and extent of drug absorption. However, repeated blood draws are not always feasible for studies using small animals because of handling or blood volume (e.g., fish or in toxicokinetic studies when only single samples can be taken per animal). Although several proposals have been published for comparing the product extent of absorption, the issue of comparative absorption rates remains unresolved. In this paper, we propose to apply the Bailer\u2013Satterthwaite\u2013Fieller confidence interval for estimating the ratio of partial area under the curve in studies that use a destructive sampling design (one blood sample per subject). To characterize the behavior of this alternative approach, we examine the impact of partial area cutoff time, blood sampling schedule, and the number of subjects included at each sampling time. Using simulated situations reflective of the issues encountered with immediate\u2010release veterinary formulations, we compare BE conclusions resulting from the use of this approach with simulated results that assuming repeated blood draws from each study subject.<\/jats:p>","DOI":"10.1111\/jvp.12934","type":"journal-article","created":{"date-parts":[[2020,12,8]],"date-time":"2020-12-08T09:13:02Z","timestamp":1607418782000},"page":"628-643","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of partial area under the curve in bioequivalence studies using destructive sampling design"],"prefix":"10.1111","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4512-853X","authenticated-orcid":false,"given":"Marilyn N.","family":"Martinez","sequence":"first","affiliation":[{"name":"Office of New Animal Drug Evaluation Center for Veterinary Medicine US Food and Drug Administration Rockville MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shasha","family":"Gao","sequence":"additional","affiliation":[{"name":"Office of New Animal Drug Evaluation Center for Veterinary Medicine US Food and Drug Administration Rockville MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,12,8]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01062139"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1011968129921"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1015842425553"},{"key":"e_1_2_9_5_1","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1111\/j.2517-6161.1954.tb00159.x","article-title":"Some problems in interval estimation","volume":"16","author":"Fieller E. C.","year":"1954","journal-title":"Journal of the Royal Statistical Society, Series B."},{"volume-title":"Pharmacokinetic and pharmacodynamic data analysis: Concepts and applications","year":"1997","author":"Gabrielsson J.","key":"e_1_2_9_6_1"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1023228925137"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.321"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1021\/js960083a"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1016255124336"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01068419"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928-006-9037-x"}],"container-title":["Journal of Veterinary Pharmacology and Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jvp.12934","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jvp.12934","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jvp.12934","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,18]],"date-time":"2024-08-18T18:10:19Z","timestamp":1724004619000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jvp.12934"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,8]]},"references-count":11,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2021,7]]}},"alternative-id":["10.1111\/jvp.12934"],"URL":"https:\/\/doi.org\/10.1111\/jvp.12934","archive":["Portico"],"relation":{},"ISSN":["0140-7783","1365-2885"],"issn-type":[{"type":"print","value":"0140-7783"},{"type":"electronic","value":"1365-2885"}],"subject":[],"published":{"date-parts":[[2020,12,8]]},"assertion":[{"value":"2020-07-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}