{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T01:42:10Z","timestamp":1747186930896,"version":"3.40.5"},"reference-count":14,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,4,3]],"date-time":"2023-04-03T00:00:00Z","timestamp":1680480000000},"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":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In a traditional blood level bioequivalence (BE) study, every subject provides drug concentrations at each blood sampling time. However, this approach is not suitable for animals whose blood volume limits or prohibits multiple sample collections. In our previous research, we presented an approach that can be applied to studies using a destructive sampling design where each animal provides only 1 blood sample that is then incorporated into a composite profile. Another situation we sometimes face is that of when the animals can contribute more than one sample but are still limited in the number of blood draws (e.g., 3) such that a complete profile per animal is not feasible. Unlike the destructive sampling situation, we cannot combine all blood samples into a single \u201ccomposite\u201d profile and ignore the correlation of values obtained from the same subject. To avoid the complexities associated with needing to include a covariance component among experimental units into the statistical model, we propose an approach whereby study subjects are randomly assigned to housing unit (e.g., cage or pen) and then randomly assigned to a sampling schedule within each housing unit. In doing so, housing unit rather than the individual subject serves as the experimental unit. This article provides an assessment of this alternative approach to assess product BE when only a limited number of samples can be obtained per study subject.<\/jats:p>","DOI":"10.1111\/jvp.13125","type":"journal-article","created":{"date-parts":[[2023,4,3]],"date-time":"2023-04-03T10:45:41Z","timestamp":1680518741000},"page":"276-299","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluation of product bioequivalence when subject blood volume necessitates limited sampling strategies"],"prefix":"10.1111","volume":"46","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 Maryland 20855 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 Maryland 20855 USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,4,3]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01062139"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1023\/a:1011968129921"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.3214"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248\u2010022\u201000769\u2010z"},{"volume-title":"Applied Biopharmaceutics & Pharmacokinetics, 7e","year":"2016","author":"Lee D. 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