Stages of drug development in clinical trials

Created by

null

Dr. Vasanth.K M.B.B.S, DNB EM, FICM, MNAMS, MBA Hospital Administration, DrNB Critical Care Medicine, Apollo main hospital.

Overview

Description

Drug development involves four main clinical trial phases. Phase I assesses safety and dosage in healthy volunteers. Phase II evaluates efficacy and side effects in patients. Phase III involves large-scale testing to confirm effectiveness and monitor adverse effects, often compared to existing treatments. After regulatory approval, Phase IV (post-marketing) monitors long-term safety and effectiveness in the general population. Each stage is crucial for ensuring the drug’s safety, effectiveness, and suitability for widespread medical use.

Author

Author image

Dr. Vasanth.K M.B.B.S, DNB EM, FICM, MNAMS, MBA Hospital Administration, DrNB Critical Care Medicine, Apollo main hospital.

Consultant Intensivist, SIMS, Vadapalani, Chennai.

Apollo Main Hospital, Chennai.