{"entities":{"Q1657971":{"pageid":1668712,"ns":120,"title":"Item:Q1657971","lastrevid":71773863,"modified":"2026-04-14T00:27:16Z","type":"item","id":"Q1657971","labels":{"en":{"language":"en","value":"Confidence region approach for assessing bioequivalence and biosimilarity accounting for heterogeneity of variability"}},"descriptions":{"en":{"language":"en","value":"scientific article; zbMATH DE number 6917487"}},"aliases":{},"claims":{"P31":[{"mainsnak":{"snaktype":"value","property":"P31","hash":"fd5912e4dab4b881a8eb0eb27e7893fef55176ad","datavalue":{"value":{"entity-type":"item","numeric-id":56887,"id":"Q56887"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","id":"Q1657971$43A913EC-6DC6-4D89-AE18-494EF45D2E07","rank":"normal"}],"P159":[{"mainsnak":{"snaktype":"value","property":"P159","hash":"cc0ebfdfdc2712a467421da954971e734f062a87","datavalue":{"value":{"text":"Confidence region approach for assessing bioequivalence and biosimilarity accounting for heterogeneity of variability","language":"en"},"type":"monolingualtext"},"datatype":"monolingualtext"},"type":"statement","id":"Q1657971$C7D59147-72A3-46AD-AD09-7D79E501BBEA","rank":"normal"}],"P225":[{"mainsnak":{"snaktype":"value","property":"P225","hash":"d3360474a6812f6fa2bcd77ecec7f6dea92f53e2","datavalue":{"value":"1403.62203","type":"string"},"datatype":"external-id"},"type":"statement","id":"Q1657971$53441C57-9A64-4D3E-9FC1-A0FA5343E07D","rank":"normal"}],"P27":[{"mainsnak":{"snaktype":"value","property":"P27","hash":"9d11e5f96d7fda3fa109cadb882e106866b224d6","datavalue":{"value":"10.1155/2015/298647","type":"string"},"datatype":"external-id"},"type":"statement","id":"Q1657971$9A5BFE56-EFBB-4EFE-860E-C0048C17F374","rank":"normal"}],"P16":[{"mainsnak":{"snaktype":"value","property":"P16","hash":"0c1288c9f1ec607c0995d5fd475c406fe3a5e339","datavalue":{"value":{"entity-type":"item","numeric-id":1657970,"id":"Q1657970"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","id":"Q1657971$62C367D8-229A-43C4-ACE3-80CBD2D4E557","rank":"normal"},{"mainsnak":{"snaktype":"value","property":"P16","hash":"7fa6aa47fcdcf6fd94baadb25ff16c905bdc2af6","datavalue":{"value":{"entity-type":"item","numeric-id":909392,"id":"Q909392"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","id":"Q1657971$294DCA69-6BCA-461B-83FE-27D2C3866D13","rank":"normal"}],"P200":[{"mainsnak":{"snaktype":"value","property":"P200","hash":"291dfa4bea40517409b4ae31a6cee6f850f4be90","datavalue":{"value":{"entity-type":"item","numeric-id":117358,"id":"Q117358"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","id":"Q1657971$F517396F-90B0-4F6D-B2BF-93D07FAE3B29","rank":"normal"}],"P28":[{"mainsnak":{"snaktype":"value","property":"P28","hash":"6fb9b273b9cb05dbe58bc28bd22b908175e93fba","datavalue":{"value":{"time":"+2018-08-14T00:00:00Z","timezone":0,"before":0,"after":0,"precision":11,"calendarmodel":"http://www.wikidata.org/entity/Q1985727"},"type":"time"},"datatype":"time"},"type":"statement","id":"Q1657971$0DEB6058-F42C-4F43-B727-F63E4B634A9A","rank":"normal"}],"P1448":[{"mainsnak":{"snaktype":"value","property":"P1448","hash":"e59e210d65a3bdf3fe2d19213470a68678d225ec","datavalue":{"value":"Summary: For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequivalence in terms of drug absorption be provided through the conduct of a bioequivalence study. A test product is said to be average bioequivalent to a reference (innovative) product if the 90\\% confidence interval of the ratio of means (after log-transformation) is totally within (80\\%, 125\\%). This approach is considered a one-parameter approach, which does not account for possible heterogeneity of variability between drug products. In this paper, we study a two-parameter approach (i.e., confidence region approach) for assessing bioequivalence, which can also be applied to assessing biosimilarity of biosimilar products. The proposed confidence region approach is compared with the traditional one-parameter approach both theoretically and numerically (i.e., simulation study) for finite sample performance.","type":"string"},"datatype":"string"},"type":"statement","id":"Q1657971$73624715-2E48-43CB-905E-50088C5A87B6","rank":"normal"}],"P226":[{"mainsnak":{"snaktype":"value","property":"P226","hash":"708a6f1a75f978962215fcdf6748c16c77f4fd6e","datavalue":{"value":"62P10","type":"string"},"datatype":"external-id"},"type":"statement","id":"Q1657971$F31F09DA-2F6C-41AB-88D5-328F639E65BF","rank":"normal"}],"P1451":[{"mainsnak":{"snaktype":"value","property":"P1451","hash":"23e56422beadc2ea290728f5054bba009beca75e","datavalue":{"value":"6917487","type":"string"},"datatype":"external-id"},"type":"statement","id":"Q1657971$6C367FBA-FCDC-4D3D-8E04-165EFAC1F571","rank":"normal"}],"P12":[{"mainsnak":{"snaktype":"value","property":"P12","hash":"d509b7e76b97ea1edd9fb5c567aecc195722299e","datavalue":{"value":"Q59114210","type":"string"},"datatype":"external-id"},"type":"statement","id":"Q1657971$5D194066-B8FE-49DE-BF59-7FA25FA10C27","rank":"normal"}],"P1460":[{"mainsnak":{"snaktype":"value","property":"P1460","hash":"57f7fea50d2ce1b39b695c4a1313582eed405e38","datavalue":{"value":{"entity-type":"item","numeric-id":5976449,"id":"Q5976449"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","id":"Q1657971$F22C884C-6728-4EEE-B741-E4AFE3DD7D8E","rank":"normal"}],"P205":[{"mainsnak":{"snaktype":"value","property":"P205","hash":"626f03d0c59a4847ca480f33f0e350d96c66e7dc","datavalue":{"value":"https://doi.org/10.1155/2015/298647","type":"string"},"datatype":"url"},"type":"statement","id":"Q1657971$D5B6C53C-3D1E-409A-B8C2-D5F86C3E43D2","rank":"normal"}],"P388":[{"mainsnak":{"snaktype":"value","property":"P388","hash":"835b211bd53ff0f0f0451e66ae8e173994609d59","datavalue":{"value":"W2210109524","type":"string"},"datatype":"external-id"},"type":"statement","id":"Q1657971$313542CA-1F2E-4250-ABB1-B062F8AD4084","rank":"normal"}],"P223":[{"mainsnak":{"snaktype":"value","property":"P223","hash":"63a94d8f463dc877c42898733dac5c7cdd22af32","datavalue":{"value":{"entity-type":"item","numeric-id":4239505,"id":"Q4239505"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","id":"Q1657971$A24148FE-300D-4C58-ADF0-299663AB7B0C","rank":"normal"},{"mainsnak":{"snaktype":"value","property":"P223","hash":"5a5963fb849cf0dcf2262cd5d180e2f11526fd73","datavalue":{"value":{"entity-type":"item","numeric-id":5775920,"id":"Q5775920"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","id":"Q1657971$E018394D-C5A9-4970-BFA9-D694ABBD5048","rank":"normal"},{"mainsnak":{"snaktype":"value","property":"P223","hash":"31f6a756e1b0434137615aff06f7c4252c039e5f","datavalue":{"value":{"entity-type":"item","numeric-id":5774569,"id":"Q5774569"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","id":"Q1657971$30E89257-1D85-4200-A4E8-2052DF5C0F24","rank":"normal"},{"mainsnak":{"snaktype":"value","property":"P223","hash":"26697e7f30d3aa5be0847fbc7ae6f35bd345548e","datavalue":{"value":{"entity-type":"item","numeric-id":5503757,"id":"Q5503757"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","id":"Q1657971$2CDF6DDB-48B1-4CE5-8CC3-E920F163A389","rank":"normal"}],"P1643":[{"mainsnak":{"snaktype":"value","property":"P1643","hash":"2ce52ff41bcfecc907e031874f14c995467c8506","datavalue":{"value":{"entity-type":"item","numeric-id":4717700,"id":"Q4717700"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","qualifiers":{"P1659":[{"snaktype":"value","property":"P1659","hash":"ef52cb47127a2ffb417ee985a82ed4641e9abf77","datavalue":{"value":{"amount":"+0.8320067524909973","unit":"1"},"type":"quantity"},"datatype":"quantity"}],"P1660":[{"snaktype":"value","property":"P1660","hash":"a327a09ea0305e98d5cf33bd4036320e19f2aed0","datavalue":{"value":{"entity-type":"item","numeric-id":6821328,"id":"Q6821328"},"type":"wikibase-entityid"},"datatype":"wikibase-item"}]},"qualifiers-order":["P1659","P1660"],"id":"Q1657971$22C6B5D2-E0AA-4BF2-AD1D-7A5319897931","rank":"normal"},{"mainsnak":{"snaktype":"value","property":"P1643","hash":"fd46fe61b1657192e0b1d15e47b834075ffa91ff","datavalue":{"value":{"entity-type":"item","numeric-id":4493435,"id":"Q4493435"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","qualifiers":{"P1659":[{"snaktype":"value","property":"P1659","hash":"ef52cb47127a2ffb417ee985a82ed4641e9abf77","datavalue":{"value":{"amount":"+0.8320067524909973","unit":"1"},"type":"quantity"},"datatype":"quantity"}],"P1660":[{"snaktype":"value","property":"P1660","hash":"a327a09ea0305e98d5cf33bd4036320e19f2aed0","datavalue":{"value":{"entity-type":"item","numeric-id":6821328,"id":"Q6821328"},"type":"wikibase-entityid"},"datatype":"wikibase-item"}]},"qualifiers-order":["P1659","P1660"],"id":"Q1657971$B985E8FA-0A1E-471A-8605-43B09C8444A5","rank":"normal"},{"mainsnak":{"snaktype":"value","property":"P1643","hash":"b2da6e5053595dfe4b29a23a56332ef64297d8ac","datavalue":{"value":{"entity-type":"item","numeric-id":1596108,"id":"Q1596108"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","qualifiers":{"P1659":[{"snaktype":"value","property":"P1659","hash":"91731d61f77101e00100d6a11176fe60861321b0","datavalue":{"value":{"amount":"+0.7871595025062561","unit":"1"},"type":"quantity"},"datatype":"quantity"}],"P1660":[{"snaktype":"value","property":"P1660","hash":"a327a09ea0305e98d5cf33bd4036320e19f2aed0","datavalue":{"value":{"entity-type":"item","numeric-id":6821328,"id":"Q6821328"},"type":"wikibase-entityid"},"datatype":"wikibase-item"}]},"qualifiers-order":["P1659","P1660"],"id":"Q1657971$18133FF0-1689-4BC1-B5CC-7D13D95EEF50","rank":"normal"},{"mainsnak":{"snaktype":"value","property":"P1643","hash":"c58b9e27763797cf4aec57b067c33094b3cf36e0","datavalue":{"value":{"entity-type":"item","numeric-id":4381684,"id":"Q4381684"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","qualifiers":{"P1659":[{"snaktype":"value","property":"P1659","hash":"b2bbb0bce1fae0cc4a1bc3a78eb3d092367cf4a4","datavalue":{"value":{"amount":"+0.7665928602218628","unit":"1"},"type":"quantity"},"datatype":"quantity"}],"P1660":[{"snaktype":"value","property":"P1660","hash":"a327a09ea0305e98d5cf33bd4036320e19f2aed0","datavalue":{"value":{"entity-type":"item","numeric-id":6821328,"id":"Q6821328"},"type":"wikibase-entityid"},"datatype":"wikibase-item"}]},"qualifiers-order":["P1659","P1660"],"id":"Q1657971$EF90B6D6-B81E-4741-8C14-075CF0B8F3CA","rank":"normal"},{"mainsnak":{"snaktype":"value","property":"P1643","hash":"e03cde58362441506a4a0505b4f4ba04efd1816e","datavalue":{"value":{"entity-type":"item","numeric-id":4239503,"id":"Q4239503"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","qualifiers":{"P1659":[{"snaktype":"value","property":"P1659","hash":"b3a9cddb701f3d8715fd7103b1dc0b82b56f0353","datavalue":{"value":{"amount":"+0.7493428587913513","unit":"1"},"type":"quantity"},"datatype":"quantity"}],"P1660":[{"snaktype":"value","property":"P1660","hash":"a327a09ea0305e98d5cf33bd4036320e19f2aed0","datavalue":{"value":{"entity-type":"item","numeric-id":6821328,"id":"Q6821328"},"type":"wikibase-entityid"},"datatype":"wikibase-item"}]},"qualifiers-order":["P1659","P1660"],"id":"Q1657971$AEF75B1A-B887-43E6-884F-3CB92F03744A","rank":"normal"}],"P163":[{"mainsnak":{"snaktype":"value","property":"P163","hash":"45fcd4163b5f33e6e8c784f5522d7246c0a1a61e","datavalue":{"value":{"entity-type":"item","numeric-id":57056,"id":"Q57056"},"type":"wikibase-entityid"},"datatype":"wikibase-item"},"type":"statement","id":"Q1657971$3A139812-B67E-4E69-B554-0D2F7B96736B","rank":"normal"}]},"sitelinks":{"mardi":{"site":"mardi","title":"Confidence region approach for assessing bioequivalence and biosimilarity accounting for heterogeneity of variability","badges":[],"url":"https://portal.mardi4nfdi.de/wiki/Confidence_region_approach_for_assessing_bioequivalence_and_biosimilarity_accounting_for_heterogeneity_of_variability"}}}}}