Phase IV
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Phase IV

Phase IV clinical studies are referred to as post-marketing or post-registration studies, this phase of studies is conducted after the state registration of the drug. This phase of studies involves the collection of data on the use, efficacy, safety and storage of the information obtained after launch of the drug onto the pharmaceutical market and its widespread use. Phase IV studies enable to obtain updated information on:

  • the use of different doses of the drug (taking into account age, sex, race and other population characteristics)
  • duration of therapy and course of treatment
  • interaction with concomitant drug therapy
  • impact on quality of life
  • long-term effects of treatment and adverse events