More FAQs
Q: FDA follows the weight-of-evidence approach. What happens when all parameters pass in vitro BE except one parameter?
A: All parameters in the in vitro tests should pass their respective BE criteria to be able to conclude BE. If one of the parameters failed, the sponsor will be advised to repeat that particular test.
The BE study is considered acceptable when the repeated test meets the BE criterion, together with adequate justifications.
Q: Is spray pattern analysis using thin layer chromatography (TLC) plates acceptable to FDA?
A: Yes, it is acceptable.
Q: Can population bioequivalence (PBE) be performed with more than 3 lots? For example, can a sponsor use 4 lots of the test drug versus 4 lots of the reference drug.
A: Yes. PBE can be performed with more than 3 lots
Q: Can PBE be performed with more than 10 units per batch?
A: Yes, more than 10 units per batch is acceptable.
Q: Various changes may take place in nasal spray product development. These changes can occur at the developmental stage, i.e., after the product passed BE tests yet pending approval, or after drug product has been approved.
Does FDA recommend a full package of BE tests for these changes?
A: In general, an abbreviated package including some in vitro tests are recommended to demonstrate BE of these changed products.
Currently, OGD handles this case-by-case. The sponsors are encouraged to consult the OGD for the specific recommendations based on their respective changes.
