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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.
Cottell, Evelyn; Michalet, Damien; Lispi, Monica; Araujo, Thiago Dantas; Gleixner, Ralf; Longobardi, Salvatore; D'Hooghe, Thomas.
Afiliación
  • Cottell E; Merck Healthcare KGaA, Darmstadt, Germany.
  • Michalet D; Ares Trading S.A. Eysins (An affiliate of Merck KGaA), Switzerland.
  • Lispi M; Merck Healthcare KGaA, Darmstadt, Germany.
  • Araujo TD; School of Clinical and Experimental Medicine, Unit of Endocrinology, University of Modena and Reggio Emilia, Modena, MO, Italy.
  • Gleixner R; Ares Trading S.A. Eysins (An affiliate of Merck KGaA), Switzerland.
  • Longobardi S; Ares Trading S.A. Eysins (An affiliate of Merck KGaA), Switzerland.
  • D'Hooghe T; Global Clinical Development, Merck Serono S.p.A, Rome, Italy, an affiliate of Merck KGaA, Darmstadt, Germany.
Expert Opin Drug Deliv ; 21(2): 337-346, 2024 Feb.
Article en En | MEDLINE | ID: mdl-38299472
ABSTRACT

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 alfalutropin-alfa 21 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 900450 IU, 450225 IU and 300150 IU follitropin alfalutropin-alfa 21 combination pen presentations.

RESULTS:

Dose accuracy tests for Vmin, Vmid and Vmax for the follitropin alfa and the follitropin alfalutropin-alfa 21 combination pen injectors, and last dose administered, were within acceptable limits according to ISO 11,608-12012/2014. 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 11608-12000/2014.

CONCLUSIONS:

The Merck family of fertility pen injectors functions reliably and the incremental dose/clicks system dispenses accurate doses.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Hormona Luteinizante / Gonadotropina Coriónica Idioma: En Revista: Expert Opin Drug Deliv Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Hormona Luteinizante / Gonadotropina Coriónica Idioma: En Revista: Expert Opin Drug Deliv Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido