Showing results for 
Show  only  | Search instead for 
Did you mean: 
Choose Language Hide Translation Bar
0 Kudos

Add Between batch bio equivalence testing proposed by Bodin et. al., AAPS journal 2020

Bioequivalence testing is an essential step during the development of generic drugs. Different methodologies are used depending on the requirement. For e.g, in the EU, EMA recommends using average bio equivalence test (ABE), while in the USA, FDA recommends using population bio equivalence (PBE) test. Both methods present some limitations. alternatively Bodin et. al., AAPS journal 2020 proposed method to evaluate bio equivalence: between-batch bio equivalence (BBE). It is based on the comparison between the mean

difference (Reference − Test) and the Reference between-batch variability.

Status changed to: Acknowledged

@Draj86 - Thank you for your suggestion! We have captured your request and will take it under consideration.

Status changed to: Investigating
Level II

This is a very good feature and will be very useful to the pharma community if it is implemented in a user friendly format in JMP.