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After the green light: Evaluating drugs in Phase IV studies

Year: 2026

Type: article

Abstract: ABSTRACT: The drug development process is lengthy and complex and Phase IV is a crucial phase within it. Phase IV studies are conducted after a drug has been approved by regulatory agencies to further evaluate its safety, efficacy, usefulness in special populations, new indications, and new formulations. There are many examples of Phase IV studies; not all Phase IV studies are postmarketing surveillance (PMS) studies, but every PMS study is an example of a Phase IV study. Phase IV studies are imperative as they evaluate the drug's effectiveness and performance in real-world clinical practice and premarketing trials have some inherent limitations. Phase IV studies can be observational or interventional studies, depending on the objectives of such studies. A drug utilization study is a Phase IV study; similarly, a registry is also an example of a Phase IV study.

Source: Indian Journal of Pharmacology

DOI: 10.4103/ijp.ijp_427_25

Authors: Bikash Ranjan Meher, Archana Mishra

Institution: All India Institute of Medical Sciences Bhubaneswar

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: hybrid

OpenAlex ID: W7159579004

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