1Student MGV’s Pharmacy College (Affiliated to Savitribai Phule Pune University), Panchavati, Nashik-422003, Maharashtra, INDIA
2Professor Vidyabharati College of pharmacy (Affiliated to Sant Gadge Baba Amravati University), Camp Road, Amravati- 444602, Maharashtra, INDIA
A phase IV clinical study is an important step in the monitoring of a new medicine after it has been approved for commercial distribution. It is a key component of post-marketing research that focuses on real-world efficacy and pharmacovigilance, not only continuing but also supplementing prior studies. Phase IV clinical trials change greatly from earlier research phases in terms of study design, criteria, and scientific demand. Phases I through III primarily test the drug's safety profile on a smaller scale, as well as its efficacy in a controlled setting of an RCT. Phase IV investigations, on the other hand, promise to identify even rarer ADRs that may have gone undetected in prior trials, as well as to assess whether the new medicine establishes its benefit on the open market, in interactions with other pharmaceuticals, and in demographic groups who were not previously accepted to the research. The goal of this article is to build up phase IV clinical studies in combination with preceding preclinical experiments to gain a better sense of the lengthy road a medicine takes—not only until it hits the market, but also afterward. Other objectives include demonstrating the relationship with various aspects of post-marketing research, investigating the present function of phase IV studies, and researching the extent to which the current situation of phase IV clinical trials satisfies needs.
Sakshi K. Loya*, Lakhan D. Baheti, A Comprehensive Review Clinical Trials: PHASE IV, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 12, 220-225. https://doi.org/10.5281/zenodo.10353554
10.5281/zenodo.10353554
