{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T23:31:09Z","timestamp":1790033469612,"version":"4.0.1"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2014,1,1]],"date-time":"2014-01-01T00:00:00Z","timestamp":1388534400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Companion Animal Fund"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2014,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Itraconazole is commonly used to treat systemic fungal infections in dogs, but problems exist with absorption and cost.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To determine oral bioequivalence of generic and compounded itraconazole compared to original innovator (brand name) itraconazole in healthy dogs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Animals<\/jats:title>\n                    <jats:p>Nine healthy, adult research Beagle dogs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A randomized, 3-way, 3-period, crossover design with an 8-day washout period. After a 12-hour fast, each dog received 100 mg (average: 10.5 mg\/kg) of either innovator itraconazole, an approved human generic capsule, or compounded itraconazole (compounded using a commercially available compounding vehicle) with a small meal. Plasma was collected at predetermined intervals for high pressure liquid chromatography analysis. Concentration data were analyzed using noncompartmental pharmacokinetics to determine area under the curve (AUC), peak concentration (CMAX), and terminal half-life. Bioequivalence tests compared generic and compounded itraconazole to the reference formulation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Average ratios of compounded and generic formulations to the reference formulation of itraconazole for AUC were 5.52% and 104.2%, respectively, and for CMAX were 4.14% and 86.34%, respectively. A test of bioequivalence using 2 one-sided tests and 90% confidence intervals did not meet bioequivalence criteria for either formulation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion and Clinical Importance<\/jats:title>\n                    <jats:p>Neither generic nor compounded itraconazole is bioequivalent to the reference formulation in dogs. However, pharmacokinetic data for generic formulation were similar enough that therapeutic concentrations could be achieved. Compounded itraconazole produced such low plasma concentrations, it is unlikely to be effective; therefore, compounded itraconazole should not be used in dogs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jvim.12219","type":"journal-article","created":{"date-parts":[[2013,11,1]],"date-time":"2013-11-01T18:12:17Z","timestamp":1383329537000},"page":"72-77","source":"Crossref","is-referenced-by-count":77,"title":["Bioequivalence of Orally Administered Generic, Compounded, and Innovator-Formulated Itraconazole in Healthy Dogs"],"prefix":"10.1093","volume":"28","author":[{"given":"D.I.","family":"Mawby","sequence":"first","affiliation":[{"name":"College of Veterinary Medicine, University of Tennessee Department of Small Animal Clinical Sciences, , Knoxville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.C.","family":"Whittemore","sequence":"additional","affiliation":[{"name":"College of Veterinary Medicine, University of Tennessee Department of Small Animal Clinical Sciences, , Knoxville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Genger","sequence":"additional","affiliation":[{"name":"College of Veterinary Medicine, University of Tennessee Department of Small Animal Clinical Sciences, , Knoxville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.G.","family":"Papich","sequence":"additional","affiliation":[{"name":"College of Veterinary Medicine, North Carolina State University Department of Molecular Biomedical Sciences, , Raleigh, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2014,1,1]]},"reference":[{"key":"2026020304345835600_jvim12219-bib-0001","first-page":"1013","volume-title":"Veterinary Pharmacology and Therapeutics","author":"Davis","year":"2009","edition":"9th ed"},{"key":"2026020304345835600_jvim12219-bib-0002","first-page":"606","volume-title":"Infectious Disease of the Dog and Cat","author":"Legendre","year":"2012","edition":"4th ed"},{"key":"2026020304345835600_jvim12219-bib-0003","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1111\/j.1939-1676.1996.tb02082.x","article-title":"Treatment of blastomycosis with itraconazole in 112 dogs","volume":"10","author":"Legendre","year":"1996","journal-title":"J Vet Intern Med"},{"key":"2026020304345835600_jvim12219-bib-0004","volume-title":"Guidance for FDA Staff and Industry: Compliance Policy Guides Manual, Sec. 608.400, Compounding of Drugs for Use in Animals","author":"US Food and Drug Administration","year":"2003"},{"key":"2026020304345835600_jvim12219-bib-0005","volume-title":"General Chapter &lt;795&gt; 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