What is a bridging study? I got this definition on google: 'A clinical trial in which a parameter of interest for a product - e.g., manufacturing process, formulation, dosing schedule – is directly compared with a changed version of that parameter with respect to the effect of the change on the product’s clinical performance'
But what does it mean?
A bridging study is a type of clinical trial conducted to compare different versions of a product, such as a drug or medical device, in terms of their clinical performance. The purpose of a bridging study is to assess the impact of a change in a specific parameter on the product's effectiveness and evaluate whether the changed version maintains similar clinical performance as the original version.
The parameter being evaluated could include various factors, such as the manufacturing process, formulation, or dosing schedule. For example, a pharmaceutical company may want to compare a new formulation of a drug with an existing one to determine if the new formulation is equally effective in treating a particular condition. In this case, the bridging study would directly compare the clinical performance of the new formulation with that of the existing formulation.
By conducting a bridging study, researchers can determine if the change in the parameter has any influence on the product's clinical performance. If the changed version shows similar clinical performance to the original version, it provides evidence that the modification is acceptable and does not compromise the product's effectiveness. This information is crucial for regulatory authorities to make informed decisions regarding the approval and use of the modified version of the product.