- March 6, 2021
- Posted by: OptimizeIAS Team
- Category: DPN Topics
Subject: Science and Technology
Context: The scientific community is divided in its opinion on the need for such a trial in current context of pandemic.
- A bridging trial performed in the new region to provide clinical data on efficacy, safety, dosage and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the population in the new region
- It provides additional pharmacokinetic information(to determine the fate of substances administered to a living organism.) in the population of the new region.
- Bridging trials are required to understand how a vaccine works on the local population, as there are issues of ethnicity, genetic variation and so on
- When no bridging study is needed to provide clinical data for efficacy, a pharmacokinetic study in the new region may be considered as a bridging study.