{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,4]],"date-time":"2025-11-04T08:44:33Z","timestamp":1762245873301,"version":"build-2065373602"},"reference-count":5,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T00:00:00Z","timestamp":1753228800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>This study evaluated the bioequivalence of enoxaparin sodium 100\u00a0mg\/1\u00a0mL solution for injection in a prefilled syringe manufactured by a generic company was compared with the reference product of the same dosage form, in healthy adult volunteers under fasting conditions. The comparison focused on pharmacodynamic (PD) parameters. This open\u2010label, randomized, balanced, 2\u2010treatment, 2\u2010period, single\u2010dose, crossover study involved 60 healthy volunteers. No serious adverse events were reported. Chromogenic assay techniques were used for sample analysis. The linearity range for PD parameters was from 0.100 to 0.800\u00a0IU\/mL for anti\u2010factor IIa activity, from 0.100 to 0.800\u00a0IU\/mL for anti\u2010factor Xa activity, and from 750.000 to 10,000.000\u00a0pg\/mL for tissue factor pathway inhibitor\u00a0quantification. Statistical analysis was conducted using SAS software Version 9.4. The PD parameters evaluated included maximum observed activity concentration, area under the effect curve from time 0 to time t, median time to maximum concentration, and terminal elimination half\u2010life for anti\u2010factor Xa and anti\u2010factor IIa activity. The 95% confidence intervals for the geometric mean ratio of log\u2010transformed PD parameters between the test and reference products for anti\u2010factor Xa and anti\u2010factor IIa activities were within the range of 80%\u2010125%. It was concluded that the test formulation is bioequivalent to the reference formulation of 100\u00a0mg\/1\u00a0mL solution for injection in a prefilled syringe, under fasting conditions.<\/jats:p>","DOI":"10.1002\/cpdd.1565","type":"journal-article","created":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T14:04:05Z","timestamp":1753279445000},"page":"821-828","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative Pharmacodynamic Bioequivalence Study of Enoxaparin Sodium 100\u00a0mg\/1\u00a0mL Solution for Injection in Prefilled Syringe in Healthy Volunteers Under Fasting Conditions"],"prefix":"10.1002","volume":"14","author":[{"given":"Naba Kumar","family":"Talukdar","sequence":"first","affiliation":[{"name":"Clinical Department, Biostatistics Department Accutest Research Laboratories Private Limited  Navi Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shailesh","family":"Sonar","sequence":"additional","affiliation":[{"name":"Biologics Bioanalytical Department Accutest Biologics Private Limited  Navi Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nisha","family":"Pal","sequence":"additional","affiliation":[{"name":"Clinical Department, Biostatistics Department Accutest Research Laboratories Private Limited  Navi Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uilberson","family":"Silva","sequence":"additional","affiliation":[{"name":"Research, Development and Innovation Department Blau Farmac\u00eautica S.A.  S\u00e3o Paulo Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,7,23]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10557-021-07251-6"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/hj.1998.v135.90304"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-019-01124-z"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0008-6215(00)81050-2"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200342120-00003"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1565","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,4]],"date-time":"2025-11-04T08:41:55Z","timestamp":1762245715000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1565"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,23]]},"references-count":5,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["10.1002\/cpdd.1565"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1565","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"type":"print","value":"2160-763X"},{"type":"electronic","value":"2160-7648"}],"subject":[],"published":{"date-parts":[[2025,7,23]]},"assertion":[{"value":"2024-10-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-23","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}