{"title":"用于生育治疗的促性腺激素 alfa 笔式注射器 2.0、促性腺激素 alfa：促性腺激素 alfa 2:1 组合笔式注射器 2.0 和促性腺激素 alfa 笔式注射器 1.0 的剂量准确性。","authors":"Evelyn Cottell, Damien Michalet, Monica Lispi, Thiago Dantas Araujo, Ralf Gleixner, Salvatore Longobardi, Thomas D'Hooghe","doi":"10.1080/17425247.2024.2311127","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>This study aimed to confirm that the incremental dose/clicks system dispenses accurate doses for the Merck family of fertility pen injectors.</p><p><strong>Research design and methods: </strong>Set doses (V<sub>set</sub>) for three dose dial settings (minimum dose [V<sub>min</sub>], midpoint dose [V<sub>mid</sub>] and maximum dose [V<sub>max</sub>] for the follitropin alfa, choriogonadotropin alfa [D2 classification: single use/variable dose], and follitropin alfa:lutropin-alfa 2:1 combination pen injectors) or a single V<sub>set</sub> for the choriogonadotropin alfa (D1 classification: single use/single dose) were assessed. Last dose administered by the multi-dose device was assessed for the 900 IU, 450 IU, 300 IU and 150 IU follitropin alfa, and the 900:450 IU, 450:225 IU and 300:150 IU follitropin alfa:lutropin-alfa 2:1 combination pen presentations.</p><p><strong>Results: </strong>Dose accuracy tests for V<sub>min</sub>, V<sub>mid</sub> and V<sub>max</sub> for the follitropin alfa and the follitropin alfa:lutropin-alfa 2:1 combination pen injectors, and last dose administered, were within acceptable limits according to ISO 11,608-1:2012/2014. Dose accuracy tests for the single use/single dose device classification and the single use/variable dose device classification of the choriogonadotropin alfa pen injector were also within the acceptable limits, according to ISO 11608-1:2000/2014.</p><p><strong>Conclusions: </strong>The Merck family of fertility pen injectors functions reliably and the incremental dose/clicks system dispenses accurate doses.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"337-346"},"PeriodicalIF":0.0000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Dose accuracy of the follitropin alfa pen injector 2.0, the follitropin alfa:lutropin alfa 2:1 combination pen injector 2.0 and the choriogonadotropin alfa pen injector 1.0 used for fertility treatment.\",\"authors\":\"Evelyn Cottell, Damien Michalet, Monica Lispi, Thiago Dantas Araujo, Ralf Gleixner, Salvatore Longobardi, Thomas D'Hooghe\",\"doi\":\"10.1080/17425247.2024.2311127\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>This study aimed to confirm that the incremental dose/clicks system dispenses accurate doses for the Merck family of fertility pen injectors.</p><p><strong>Research design and methods: </strong>Set doses (V<sub>set</sub>) for three dose dial settings (minimum dose [V<sub>min</sub>], midpoint dose [V<sub>mid</sub>] and maximum dose [V<sub>max</sub>] for the follitropin alfa, choriogonadotropin alfa [D2 classification: single use/variable dose], and follitropin alfa:lutropin-alfa 2:1 combination pen injectors) or a single V<sub>set</sub> for the choriogonadotropin alfa (D1 classification: single use/single dose) were assessed. Last dose administered by the multi-dose device was assessed for the 900 IU, 450 IU, 300 IU and 150 IU follitropin alfa, and the 900:450 IU, 450:225 IU and 300:150 IU follitropin alfa:lutropin-alfa 2:1 combination pen presentations.</p><p><strong>Results: </strong>Dose accuracy tests for V<sub>min</sub>, V<sub>mid</sub> and V<sub>max</sub> for the follitropin alfa and the follitropin alfa:lutropin-alfa 2:1 combination pen injectors, and last dose administered, were within acceptable limits according to ISO 11,608-1:2012/2014. Dose accuracy tests for the single use/single dose device classification and the single use/variable dose device classification of the choriogonadotropin alfa pen injector were also within the acceptable limits, according to ISO 11608-1:2000/2014.</p><p><strong>Conclusions: </strong>The Merck family of fertility pen injectors functions reliably and the incremental dose/clicks system dispenses accurate doses.</p>\",\"PeriodicalId\":94004,\"journal\":{\"name\":\"Expert opinion on drug delivery\",\"volume\":\" \",\"pages\":\"337-346\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert opinion on drug delivery\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1080/17425247.2024.2311127\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/2/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert opinion on drug delivery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/17425247.2024.2311127","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/2 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
Dose accuracy of the follitropin alfa pen injector 2.0, the follitropin alfa:lutropin alfa 2:1 combination pen injector 2.0 and the choriogonadotropin alfa pen injector 1.0 used for fertility treatment.
Background: This study aimed to confirm that the incremental dose/clicks system dispenses accurate doses for the Merck family of fertility pen injectors.
Research design and methods: Set doses (Vset) for three dose dial settings (minimum dose [Vmin], midpoint dose [Vmid] and maximum dose [Vmax] for the follitropin alfa, choriogonadotropin alfa [D2 classification: single use/variable dose], and follitropin alfa:lutropin-alfa 2:1 combination pen injectors) or a single Vset for the choriogonadotropin alfa (D1 classification: single use/single dose) were assessed. Last dose administered by the multi-dose device was assessed for the 900 IU, 450 IU, 300 IU and 150 IU follitropin alfa, and the 900:450 IU, 450:225 IU and 300:150 IU follitropin alfa:lutropin-alfa 2:1 combination pen presentations.
Results: Dose accuracy tests for Vmin, Vmid and Vmax for the follitropin alfa and the follitropin alfa:lutropin-alfa 2:1 combination pen injectors, and last dose administered, were within acceptable limits according to ISO 11,608-1:2012/2014. Dose accuracy tests for the single use/single dose device classification and the single use/variable dose device classification of the choriogonadotropin alfa pen injector were also within the acceptable limits, according to ISO 11608-1:2000/2014.
Conclusions: The Merck family of fertility pen injectors functions reliably and the incremental dose/clicks system dispenses accurate doses.
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