{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T01:04:19Z","timestamp":1787879059950,"version":"build-2784847793"},"reference-count":20,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,3,20]],"date-time":"2020-03-20T00:00:00Z","timestamp":1584662400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Tafamidis, a non\u2010nonsteroidal anti\u2010inflammatory benzoxazole derivative, acts as a transthyretin (TTR) stabilizer to slow progression of TTR amyloidosis (ATTR). Tafamidis meglumine, available as 20\u2010mg capsules, is approved in more than 40 countries worldwide for the treatment of adults with early\u2010stage symptomatic ATTR polyneuropathy. This agent, administered as an 80\u2010mg, once\u2010daily dose (4 \u00d7 20\u2010mg capsules), is approved in the United States, Japan, Canada, and Brazil for the treatment of hereditary and wild\u2010type ATTR cardiomyopathy in adults. An alternative single solid oral dosage formulation (tafamidis 61\u2010mg free acid capsules) was developed and introduced for patient convenience (approved in the United States, United Arab Emirates, and European Union). In this single\u2010center, open\u2010label, randomized, 2\u2010period, 2\u2010sequence, crossover, multiple\u2010dose phase 1 study, the rate and extent of absorption were compared between tafamidis 61\u2010mg free acid capsules (test) and tafamidis meglumine 80\u2010mg (4 \u00d7 20\u2010mg) capsules (reference) after 7 days of repeated oral dosing under fasted conditions in 30 healthy volunteers. Ratios of adjusted geometric means (90%CI) for the test\/reference formulations were 102.3 (98.0\u2010106.8) for area under the concentration\u2010time profile over the dosing interval and 94.1 (89.1\u201099.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80\u2010125). Both tafamidis regimens had an acceptable safety\/tolerability profile in this population.<\/jats:p>","DOI":"10.1002\/cpdd.789","type":"journal-article","created":{"date-parts":[[2020,3,20]],"date-time":"2020-03-20T14:48:47Z","timestamp":1584715727000},"page":"849-854","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":54,"title":["The Bioequivalence of Tafamidis 61\u2010mg Free Acid Capsules and Tafamidis Meglumine 4 \u00d7 20\u2010mg Capsules in Healthy Volunteers"],"prefix":"10.1002","volume":"9","author":[{"given":"Peter A.","family":"Lockwood","sequence":"first","affiliation":[{"name":"Pfizer  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vu H.","family":"Le","sequence":"additional","affiliation":[{"name":"Pfizer  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa T.","family":"O'Gorman","sequence":"additional","affiliation":[{"name":"Pfizer  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terrell A.","family":"Patterson","sequence":"additional","affiliation":[{"name":"Pfizer  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marla B.","family":"Sultan","sequence":"additional","affiliation":[{"name":"Pfizer  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ekaterina","family":"Tankisheva","sequence":"additional","affiliation":[{"name":"Pfizer  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiang","family":"Wang","sequence":"additional","affiliation":[{"name":"Pfizer Beijing City  China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steve","family":"Riley","sequence":"additional","affiliation":[{"name":"Pfizer  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,3,20]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/1831202a0"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9440(10)63050-7"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.0400062101"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.7754382"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmb.2011.12.060"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/biomedicines7010011"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/msj.21352"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.111.078915"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1121005109"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.2217\/fca-2018-0078"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-016-0040-x"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3182661eb1"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00415-013-7051-7"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/13506129.2017.1357545"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/13506129.2016.1207163"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-019-01129-6"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1805689"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12561"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1517\/21678707.2013.841576"},{"key":"e_1_2_8_21_1","unstructured":"US Food and Drug Administration.CVM GFI #224 (VICH GL52) Bioequivalence: blood level bioequivalence study.2016.https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/cvm-gfi-224-vich-gl52-bioequivalence-blood-level-bioequivalence-study. 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