Nonclinical pharmacology and toxicology of the first biosimilar insulin glargine drug product (BASAGLAR<sup>®</sup>/ABASAGLAR<sup>®</sup>) approved in the European Union.

Byrd, Richard A; Owens, Rebecca A; Blackbourne, Jamie L; Coutant, David E; Farmen, Mark W; Michael, M Dodson; Moyers, Julie S; Schultze, A Eric; Sievert, Michael K; Tripathi, Niraj K; Vahle, John L

Nonclinical pharmacology and toxicology of the first biosimilar insulin glargine drug product (BASAGLAR^®/ABASAGLAR^®) approved in the European Union.

Byrd, Richard A; Owens, Rebecca A; Blackbourne, Jamie L; Coutant, David E; Farmen, Mark W; Michael, M Dodson; Moyers, Julie S; Schultze, A Eric; Sievert, Michael K; Tripathi, Niraj K; Vahle, John L.

Afiliação

Byrd RA; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA. Electronic address: byrd_richard_a@lilly.com.
Owens RA; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Blackbourne JL; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Coutant DE; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Farmen MW; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Michael MD; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Moyers JS; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Schultze AE; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Sievert MK; Covance Laboratories, Inc., Madison, WI, USA.
Tripathi NK; Covance Laboratories, Inc., Madison, WI, USA.
Vahle JL; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA.

Regul Toxicol Pharmacol ; 88: 56-65, 2017 Aug.

Article em En | MEDLINE | ID: mdl-28526658

Assuntos

Medicamentos Biossimilares/toxicidade; Hipoglicemiantes/toxicidade; Insulina Glargina/toxicidade; Animais; Medicamentos Biossimilares/metabolismo; Aprovação de Drogas; União Europeia; Humanos; Hipoglicemia/induzido quimicamente; Hipoglicemiantes/metabolismo; Técnicas In Vitro; Insulina Glargina/metabolismo; Ratos; Receptor IGF Tipo 1/metabolismo; Receptor de Insulina/metabolismo

Palavras-chave

Biosimilar insulin; Glucodynamics; Insulin glargine; Nonclinical; Pharmacokinetics; Pharmacology; Preclinical; Rats; Toxicology

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares / Insulina Glargina / Hipoglicemiantes Limite: Animals / Humans Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2017 Tipo de documento: Article

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