{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T22:53:53Z","timestamp":1777416833689,"version":"3.51.4"},"reference-count":24,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[1987,4,1]],"date-time":"1987-04-01T00:00:00Z","timestamp":544233600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Drug Intelligence &amp; Clinical Pharmacy"],"published-print":{"date-parts":[[1987,4]]},"abstract":"<jats:p>The phenothiazines are among the most widely used drugs to treat symptoms commonly associated with acute and chronic psychoses. One of the commonly prescribed compounds within this class of drugs is thioridazine, available both as a generic product as well as the innovator product, Mellaril. Each of these products is coded as bioequivalent and consequently therapeutically equivalent by the Food and Drug Administration (FDA). A recent issue of this journal contained an article that raised a number of questions concerning the bioequivalence of the generic versions of thioridazine that have been approved by the FDA. Their article was based in part on information obtained from the FDA as well as information supplied to the authors by Sandoz, Inc., the manufacturer of the original thioridazine drug product Mellaril. The FDA has reviewed its original decision of bioequivalence. Based on this reassessment, the FDA strongly rejects the assertion by the authors that several of the approved generic thioridazine products are not bioequivalent. The rationale behind the FDA decisions and the FDA's viewpoint on the bioequivalence of generic thioridazine drug products is discussed in detail.<\/jats:p>","DOI":"10.1177\/106002808702100413","type":"journal-article","created":{"date-parts":[[2017,2,13]],"date-time":"2017-02-13T11:52:47Z","timestamp":1486986767000},"page":"362-369","source":"Crossref","is-referenced-by-count":6,"title":["Bioequivalence of Generic Thioridazine Drug Products\u2014The FDA Viewpoint"],"prefix":"10.1177","volume":"21","author":[{"given":"Michael R.","family":"Hamrell","sequence":"first","affiliation":[{"name":"Division of Bioequivalence"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marilyn N.","family":"Martinez","sequence":"additional","affiliation":[{"name":"Division of Bioequivalence"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shrikant V.","family":"Dighe","sequence":"additional","affiliation":[{"name":"Division of Bioequivalence"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul D.","family":"Parkman","sequence":"additional","affiliation":[{"name":"Center for Drugs &amp; Biologics, Food and Drug Administration, Rockville, MD 20857."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[1987,4]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1177\/106002808501901124"},{"key":"e_1_2_1_3_2","author":"Sandoz Inc.","year":"1984","unstructured":"Sandoz Inc. Comparison of bioavailability\/bioequivalence characteristics of Mellaril, thioridazine, and seven generic thioridazine formulations. Vols. I\u2013III. East Hanover, NJ, 1984.","journal-title":"Comparison of bioavailability\/bioequivalence characteristics of Mellaril, thioridazine, and seven generic thioridazine formulations."},{"key":"e_1_2_1_4_2","first-page":"312","article-title":"Author's reply (letter).","volume":"20","author":"Barone JA","year":"1986","unstructured":"BaroneJA, ColaizziJL. Author's reply (letter). Drug Inlell Clin Pharm 1986; 20: 312.","journal-title":"Drug Inlell Clin Pharm"},{"key":"e_1_2_1_5_2","first-page":"311","article-title":"Comment: thioridazine bioequivalence (letter).","volume":"20","author":"Meyer HM","year":"1986","unstructured":"MeyerHM. Comment: thioridazine bioequivalence (letter). Drug Inlell Clin Pharm 1986; 20: 311.","journal-title":"Drug Inlell Clin Pharm"},{"key":"e_1_2_1_6_2","first-page":"391","volume-title":"Goodman and Gilman's the pharmacological basis of therapeutics.","author":"Baldessarini RJ","year":"1985","unstructured":"BaldessariniRJ. Drugs and the treatment of psychiatric disorders. In: GilmanA, GoodmanLS, RallTW, MuradF, eds. Goodman and Gilman's the pharmacological basis of therapeutics. 7th ed. New York: Macmillan, 1985: 391\u2013408.","edition":"7"},{"key":"e_1_2_1_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0010-440X(75)80002-2"},{"key":"e_1_2_1_8_2","first-page":"587","article-title":"On the serum concentrations and antipsychotic effects of thioridazine, thioridazine side-chain sulfoxide and thioridazine side-chain sulf\u00f2ne in chronic psychiatric patients.","volume":"21","author":"Axelsson RA","year":"1977","unstructured":"AxelssonRA. On the serum concentrations and antipsychotic effects of thioridazine, thioridazine side-chain sulfoxide and thioridazine side-chain sulf\u00f2ne in chronic psychiatric patients. Curr Ther Res 1977; 21: 587\u2013605.","journal-title":"Curr Ther Res"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0378-4347(00)81862-9"},{"key":"e_1_2_1_10_2","first-page":"561","article-title":"The concentration pattern of nonconjugated thioridazine metabolites in serum by thioridazine treatment and its relationship to physiological and clinical variables.","volume":"21","author":"Axelsson R","year":"1977","unstructured":"AxelssonR, MartenssonE. The concentration pattern of nonconjugated thioridazine metabolites in serum by thioridazine treatment and its relationship to physiological and clinical variables. 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