Modern approach to the evaluation of the pharmacokinetics and pharmacodynamics of biosimilar recombinant human insulin and insulin analogues in I phase clinical study

The quality, pharmacokinetic and pharmacodynamic profiles, safety and immunogenicity must be compared to demonstrate the bio-similarities of recombinant human insulin and insulin analogues. To confirm these bio-similarities in clinical studies, it is necessary to adhere to a multi-phased approach, s...

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Bibliographic Details
Main Authors: Irina A. Proskurina, Alexander Y. Mayorov, Dmitriy V. Gorachev, Natalya D. Bunyatyan
Format: Article
Language:English
Published: Endocrinology Research Centre 2016-07-01
Series:Сахарный диабет
Subjects:
Online Access:https://dia-endojournals.ru/dia/article/viewFile/7793/5871