{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T07:48:41Z","timestamp":1768549721941,"version":"3.49.0"},"reference-count":26,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2006,11,2]],"date-time":"2006-11-02T00:00:00Z","timestamp":1162425600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vet Pharm &amp; Therapeutics"],"published-print":{"date-parts":[[2006,12]]},"abstract":"<jats:p>The bolus (or oblet) is a dosage form that can be used for the oral administration of pharmaceutical compounds to ruminating species. Unlike traditional tablets, oral boluses may contain quantities of drug on the order of grams rather than milligrams. Due to its size, it is only recently that USP\u2010like <jats:italic>in vitro<\/jats:italic> dissolution methods have been developed for this dosage form. However, whether or not these dissolution tests can predict product <jats:italic>in vivo<\/jats:italic> performance has yet to be determined. The importance of this issue is apparent when the U.S. Food and Drug Administration Center for Veterinary Medicine is faced with the decision of whether to require additional <jats:italic>in vivo<\/jats:italic> bioequivalence study data to support the approval of changes in product chemistry or manufacturing method. The current study was undertaken to determine whether an <jats:italic>in vivo<\/jats:italic>\/<jats:italic>in vitro<\/jats:italic> correlation can be established for bovine sulfamethazine oral boluses and to acquire insight into the magnitude of changes in <jats:italic>in vitro<\/jats:italic> product performance that can occur before corresponding changes are seen in <jats:italic>in vivo<\/jats:italic> blood level profiles. Based upon the results of this investigation, it is concluded that marked changes in <jats:italic>in vitro<\/jats:italic> sulfamethazine bolus performance can be tolerated before resulting in altered <jats:italic>in vivo<\/jats:italic> blood level profiles. However, the data also suggest that rumenal absorption may occur for some compounds. Therefore the degree to which variation in product <jats:italic>in vitro<\/jats:italic> dissolution profiles can be tolerated may be compound specific.<\/jats:p>","DOI":"10.1111\/j.1365-2885.2006.00781.x","type":"journal-article","created":{"date-parts":[[2006,11,2]],"date-time":"2006-11-02T23:03:13Z","timestamp":1162508593000},"page":"459-467","source":"Crossref","is-referenced-by-count":4,"title":["Comparison of bovine <i>in vivo<\/i> bioavailability of two sulfamethazine oral boluses exhibiting different <i>in vitro<\/i> dissolution profiles"],"prefix":"10.1111","volume":"29","author":[{"given":"M. N.","family":"MARTINEZ","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. C.","family":"KAWALEK","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K. D.","family":"HOWARD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. L.","family":"WARD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"MARROUM","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W.","family":"MARNANE","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"BENSLEY","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F. R.","family":"PELSOR","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"HOAG","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A. S.","family":"TATAVARTI","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"XIE","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.","family":"FAHMY","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2006,11,2]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1016212804288"},{"key":"e_1_2_6_3_1","volume-title":"Hypertext Book Pathophysiology of the Digestive System","author":"Austgen L.","year":"1998"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600660503"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1211\/002235702847"},{"key":"e_1_2_6_6_1","first-page":"1406","volume-title":"Encyclopedia of Chemicals, Drugs and Biologicals","author":"Budavari S.","year":"1989"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2885.1991.tb00802.x"},{"key":"e_1_2_6_8_1","first-page":"1","article-title":"Dissolution testing of veterinary dosage forms","author":"Fahmy R.","year":"2001","journal-title":"Dissolution Technology"},{"key":"e_1_2_6_9_1","first-page":"80","article-title":"Effect of equipment and manufacturing process changes on the quality attributes of sulfamethazine boluses","volume":"27","author":"Fahmy R.M.","year":"2003","journal-title":"Pharmaceutical Technology"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1079\/BJN19780097"},{"key":"e_1_2_6_11_1","unstructured":"FDA\/CDER Guidance for Industry(1995)SUPAC\u2010IR: Immediate\u2010Release Solid Oral Dosage Forms: Scale\u2010Up and Post\u2010Approval Changes: Chemistry Manufacturing and Controls In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation dated 11\/1995.http:\/\/www.fda.gov\/cder\/guidance\/cmc5.pdf(accessed on 14 February 2006)."},{"key":"e_1_2_6_12_1","unstructured":"FDA\/CDER Guidance for Industry(1997a)Extended Release Oral Dosage Forms: Development Evaluation and Application of In Vitro\/In Vivo Correlations(Issued 9\/1997 Posted 9\/26\/1997).http:\/\/www.fda.gov\/cder\/guidance\/1306fnl.pdf(accessed on 14 February 2006)."},{"key":"e_1_2_6_13_1","unstructured":"FDA\/CDER Guidance for Industry(1997b)SUPAC\u2010MR: Modified Release Solid Oral Dosage Forms Scale\u2010Up and Postapproval Changes: Chemistry Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation(Issued 10\/6\/1997 Posted 10\/6\/1997).http:\/\/www.fda.gov\/cder\/guidance\/1214fnl.pdf(accessed on 14 February 2006."},{"key":"e_1_2_6_14_1","unstructured":"FDA\/CDER Guidance for Industry(2000)Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate\u2010Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System dated 08\/2000.http:\/\/www.fda.gov\/cder\/guidance\/3618fnl.pdf(accessed on 7 July 2006)."},{"key":"e_1_2_6_15_1","unstructured":"FDA\/CVM Guidance for Industry(2002)Bioequivalence Guideline (#35) dated 10\/09\/2002.http:\/\/www.fda.gov\/cvm\/Guidance\/bioequivalence_Oct02.pdf(accessed on 15 February 2006)."},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600651231"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01065657"},{"key":"e_1_2_6_18_1","volume-title":"From Feed To Milk: Understanding Rumen Function","author":"Ishler V.","year":"1996"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02353672"},{"key":"e_1_2_6_20_1","first-page":"2","article-title":"Veterinary application of in vitro dissolution data and the biopharmaceutics classification system","volume":"30","author":"Martinez M.N.","year":"2004","journal-title":"Pharmacopeial Forum"},{"key":"e_1_2_6_21_1","volume-title":"Guide for the Care and Use of Laboratory Animals","author":"National Research Council","year":"1996"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1080\/01652176.1985.9693980"},{"key":"e_1_2_6_23_1","first-page":"642","article-title":"Age and dosage dependency in the plasma disposition and the renal clearance of sulfamethazine and its N4\u2010acetyl and hydroxy metabolites in calves and cows","volume":"47","author":"Nouws J.F.","year":"1986","journal-title":"American Journal of Veterinary Research"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/jps.20064"},{"key":"e_1_2_6_25_1","first-page":"229","author":"U.S. Food and Drug Administration","year":"2001","journal-title":"Good Laboratory Practice Regulations for Nonclinical Laboratory Studies"},{"key":"e_1_2_6_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600520629"},{"key":"e_1_2_6_27_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1012252822432"}],"container-title":["Journal of Veterinary Pharmacology and Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1365-2885.2006.00781.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1365-2885.2006.00781.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,11]],"date-time":"2023-10-11T20:46:01Z","timestamp":1697057161000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1365-2885.2006.00781.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2006,11,2]]},"references-count":26,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2006,12]]}},"alternative-id":["10.1111\/j.1365-2885.2006.00781.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1365-2885.2006.00781.x","archive":["Portico"],"relation":{},"ISSN":["0140-7783","1365-2885"],"issn-type":[{"value":"0140-7783","type":"print"},{"value":"1365-2885","type":"electronic"}],"subject":[],"published":{"date-parts":[[2006,11,2]]}}}