Generic bioequivalence study management
- Biosimilar drug product— pharmaceutically equivalent and pharmaceutically alternative products with relatively similar bioavailability when compared in fair experimental conditions.
- Main bioequivalence criteria – degree and velocity of absorption of the drug substance, time to maximum observed plasma drug concentration, distribution pattern in tissues and body fluids, type and rate of product elimination.
- Two drug products are biosimilar if they are pharmaceutically equivalent and pharmaceutically alternative, and if their bioavailability after injection of the same molar dose is so similar, that their efficacy and safety are mostly similar.
- According to Federal law №61-ФЗ «On Medicine Circulation», without proof of bioequivalence generic can not be licensed in the Russian Federation.
«SOLYUR Pharmaceuticals Group» performs bioequivalence study management strictly according to the International guide for Good clinical practice (ICH GCP).
Our employees provide timely and high-quality services at any stage of a clinical trial, namely :
- Development and production of clinical documentation (protocol, investigator drug brochure, patient information sheet, case Report Form)
- Life- and health-insurance for volunteers
- Selection and evaluation of potentially suitable research and analytical centers
- Organizing of the clinical part of the study
- Monitoring of bioequivalence studies
- Organizing of the analytical part of the study
- Production of final report