clinical review 3 phases – these are extended CIs, which are held with the participation, usually, several thousand subjects and are as close as possible to real clinical practice. The exception is limited CI of the 3rd phase, number of patients in which there may be 100-500 Human.

Purpose of clinical trials

The main goal of the phase 3 CT is to confirm the data obtained on the safety and effectiveness of the drug for various human populations. The dependence of the effect of the drug on the age of the subjects is revealed, influence of concomitant pathologies, therapeutic benefit, the maximum and minimum doses are specified. After these studies have been completed, the registration procedure for the drug can begin..

Registration of the preparation

Allocate 2 stage:

• 3a – the period from the start of testing the drug on the specified group of patients, before submission for registration.
• 3b – the period from filing an application to the final registration of a medicinal product.

The total duration of the first three phases of a clinical trial usually depends on the type of drug and the range of its use.. The usual period for conducting pre-registration studies is no less than 3-4 years.