Modern approach to the evaluation of the pharmacokinetics and pharmacodynamics of biosimilar recombinant human insulin and insulin analogues in I phase clinical study
| Autor: | Natalya D. Bunyatyan, Dmitriy V. Gorachev, Alexander Yur'evich Mayorov, Irina A. Proskurina |
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| Rok vydání: | 2016 |
| Předmět: |
Drug
medicine.medical_specialty RC620-627 insulin analogues Endocrinology Diabetes and Metabolism medicine.medical_treatment media_common.quotation_subject 030209 endocrinology & metabolism 030204 cardiovascular system & hematology Pharmacology law.invention 03 medical and health sciences 0302 clinical medicine Endocrinology Pharmacokinetics law Internal medicine Internal Medicine Human insulin Medicine Nutritional diseases. Deficiency diseases media_common recombinant human insulin business.industry Insulin Immunogenicity euglycaemic hyperinsulinaemic clamp-study Biosimilar Pharmacodynamics Recombinant DNA biosimilar business |
| Zdroj: | Сахарный диабет, Vol 19, Iss 3, Pp 251-259 (2016) |
| ISSN: | 2072-0378 2072-0351 |
| Popis: | 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, starting with the pharmacokinetics and pharmacodynamics of the study drugs. In this article, in accordance with modern approaches to drug research, evaluation of the pharmacokinetics and pharmacodynamics of recombinant human insulin and analogues of human insulin (biosimilar drugs) is performed in a double-blind, randomised crossover euglycaemic hyperinsulinaemic clamp study.This article describes the main approaches to the evaluation of the pharmacokinetic and pharmacodynamic parameters of recombinant human insulin preparations and insulin analogues during a euglycaemic hyperinsulinaemic clamp study. The inclusion criteria for the sample selection, design and conditions of the study, methods for the suppression of endogenous insulin, recommendations for doses of drugs, duration of the study and choice of primary and secondary pharmacokinetic and pharmacodynamic parameters for bio-similar insulin products (which depend on the duration of their effects) are described. |
| Databáze: | OpenAIRE |
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