{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T02:26:51Z","timestamp":1740104811441,"version":"3.37.3"},"reference-count":20,"publisher":"Wiley","issue":"19","license":[{"start":{"date-parts":[[2017,5,11]],"date-time":"2017-05-11T00:00:00Z","timestamp":1494460800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2017,5,11]],"date-time":"2017-05-11T00:00:00Z","timestamp":1494460800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1"},{"start":{"date-parts":[[2017,5,11]],"date-time":"2017-05-11T00:00:00Z","timestamp":1494460800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions"}],"content-domain":{"domain":["wiley.com"],"crossmark-restriction":true},"short-container-title":["Statistics in Medicine"],"published-print":{"date-parts":[[2017,8,30]]},"abstract":"<jats:p>As more and more generics become available in the market place, the safety\/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovative drug product is not required. In practice, approved generics are often used interchangeably without any mechanism of safety monitoring. In this article, based on indirect comparisons, we proposed several methods to assessing bioequivalence and interchangeability between generics. The applicability of the methods and the similarity assumptions were discussed, as well as the inappropriateness of directly adopting adjusted indirect comparison to the field of generics' comparison. Besides, some extensions were given to take into consideration the important topics in clinical trials for bioequivalence assessments, for example, multiple comparisons and simultaneously testing bioequivalence among three generics. Extensive simulation studies were conducted to investigate the performances of the proposed methods. The studies of malaria generics and HIV\/AIDS generics prequalified by the WHO were used as real examples to demonstrate the use of the methods. Copyright \u00a9 2017 John Wiley &amp; Sons, Ltd.<\/jats:p>","DOI":"10.1002\/sim.7326","type":"journal-article","created":{"date-parts":[[2017,5,12]],"date-time":"2017-05-12T01:06:11Z","timestamp":1494551171000},"page":"2978-2993","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["On assessing bioequivalence and interchangeability between generics based on indirect comparisons"],"prefix":"10.1002","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5559-6847","authenticated-orcid":false,"given":"Jiayin","family":"Zheng","sequence":"first","affiliation":[{"name":"National Clinical Research Center for Digestive Disease Beijing Friendship Hospital, Capital Medical University  Beijing China"},{"name":"Duke University School of Medicine  2424 Erwin Road, Hock Plaza, Suite 1102 Durham 27705 NC U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shein\u2010Chung","family":"Chow","sequence":"additional","affiliation":[{"name":"National Clinical Research Center for Digestive Disease Beijing Friendship Hospital, Capital Medical University  Beijing China"},{"name":"Duke University School of Medicine  2424 Erwin Road, Hock Plaza, Suite 1102 Durham 27705 NC U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mengdie","family":"Yuan","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research Organization Food and Drug Administration  Silver Spring Maryland U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,5,11]]},"reference":[{"volume-title":"Design and Analysis of Bioavailability and Bioequivalence Studies","year":"2009","author":"Chow SC","key":"e_1_2_11_2_1"},{"volume-title":"Guidance for Industry: Statistical Approaches to Establishing 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