Bioequivalence and Bioavailability Forum

Hi olacy!

❝ Would you please explain me what bridging study means?

If you want to close the gap between safety/efficacy data gathered in one population (e.g., Caucasians) to another population (e.g. Japanese) who are considered to be different in their metabolizing pattern.
Therefore the term 'bridging' (between ICH regions).
The design is always parallel groups; but may be rather tricky in finding the 'right way' of interpretation (there is an ongoing debate about inclusion criteria according to body weight, and/or BMI, etc.)

❝ When and why is it needed?

1. See above
2. ICH E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data and
   E5: Ethnic Factors in the Acceptability of Foreign Clinical Data; Questions & Answers (R1)

Regards,
Hermann

P.S.: Some people use the term also for BE-studies, where the innovator 'bridges' from the formulation used in clinical phases I-III to the final market formulation.