Failed BE study Analysis

Failed BE study Analysis

When bioequivalence study fails to show bioequivalence, still such data – when subjected to proper investigation by experts – provides immense valuable insight and clear guidance to strategize the future course of action through the determination of the root cause of such failure.
The investigation should start from formulation strategy, pharmacokinetic parameters and dissolution data for establishing possible IVIVC correlation etc. Other factors such as study design, enrolled population, sample size, time points, bioanalytical issues, food effect, dietary factors are also critical and should not be missed. There can be multiple reasons behind failure of a BE study and repeating the study without knowing them may turn out to be another blunder.
An integrated approach should be planned with engagement of experts from formulation, biostatistics, clinical and bioanalytical as needed. Problematic areas need to be identified and studied in detail to make conclusions, while auditing and validating the data correctness.
Investigation of failed bioequivalence study is beyond the scope of a CRO and is a big loss to the sponsor financially as well as it delays the timelines. As a company you cannot expect the same team to find out the loophole in a study which conducted it. You need an independent entity to assess the BE study and help you with the root cause analysis.
Based on the detail Root Cause Analysis, we could sort out the reason for failure and put forth new strategies and further actions required, whether it is returning to the formulation development strategy or using different design approach or increasing sample size etc. Expert Consult has system based investigational approach and stepwise investigation strategy for investigating failed studies which has led to successful solutions and corrective measures to ensure a successful outcome at the end.