PharmAssistance - clinical research, regulatory services and pharmacovigilance

This section provides a description of the main phases of clinical trials

Bioequivalence testing

Comparison of the equivalence of two drugs - investigational and original - in healthy people (volunteers).

The first phase serves to assess the safety of the drug in a limited number of people and is an introductory

clinical review 2 phases Studies are carried out on a sufficiently large contingent of patients - 100-300 man sometimes 500

clinical review 3 phases - these are extended CIs, which are held with the participation, usually, several thousand test subjects

After the drug is registered and marketing authorization is obtained, CTs may be performed 4 phases