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JMP Wish List

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0 Kudos

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

Status: Investigating Submitted by on ‎10-18-2022 12:56 AM
3 Comments (3 New)

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.

3 Comments
Sarah-Sylvestre
Staff
Staff
‎10-19-2022 02:34 PM
‎10-19-2022 02:34 PM
Status changed to: Acknowledged

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

SamGardner
Staff
Staff
‎12-08-2022 10:41 AM
‎12-08-2022 10:41 AM
Status changed to: Investigating
 
priyanshpandya
Level II
‎12-14-2022 06:53 AM
‎12-14-2022 06:53 AM

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.