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...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Endocrinology Research Centre
2016-07-01
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| Series: | Сахарный диабет |
| Subjects: | |
| Online Access: | https://dia-endojournals.ru/dia/article/viewFile/7793/5871 |