Bioequivalence of Reference and Biosimilar Preparations of Premixed Biphasic Insulin Aspart: A Comparative Clamp Study.

Dorotenko, Artem; Makarenko, Igor; Karonova, Tatiana; Protsenko, Ekaterina; Gefen, Maria; Galstyan, Gagik; Antonova, Elizaveta; Shitov, Leonid; Dzhurko, Yurij; Drai, Roman

Dorotenko, Artem; Makarenko, Igor; Karonova, Tatiana; Protsenko, Ekaterina; Gefen, Maria; Galstyan, Gagik; Antonova, Elizaveta; Shitov, Leonid; Dzhurko, Yurij; Drai, Roman.

Affiliation

Dorotenko A; R&D Center, GEROPHARM, Saint-Petersburg, Russia.
Makarenko I; R&D Center, GEROPHARM, Saint-Petersburg, Russia.
Karonova T; Institute of Endocrinology, Almazov National Medical Research Center, Saint Petersburg, Russia.
Protsenko E; R&D Center, GEROPHARM, Saint-Petersburg, Russia.
Gefen M; R&D Center, GEROPHARM, Saint-Petersburg, Russia.
Galstyan G; Endocrinology Research Center, Moscow, Russia.
Antonova E; JSC Modern Medical Technologies, Saint-Petersburg, Russia.
Shitov L; KAYAR LTD, Yaroslavl, Russia.
Dzhurko Y; KAYAR LTD, Yaroslavl, Russia.
Drai R; R&D Center, GEROPHARM, Saint-Petersburg, Russia.

Clin Pharmacol Drug Dev ; 12(12): 1178-1184, 2023 12.

Article de En | MEDLINE | ID: mdl-37728234

Sujet(s)
Mots clés

biosimilar; biphasic insulin aspart 30; hyperinsulinemic euglycemic clamp; phase I study; premixed insulin analogs

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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Insulines biphasiques / Produits pharmaceutiques biosimilaires Type d'étude: Clinical_trials Limites: Humans / Male Langue: En Journal: Clin Pharmacol Drug Dev Année: 2023 Type de document: Article Pays d'affiliation: Russie

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