Table 2 Justifications for rejecting 51 trials

Reasons for rejecting BE studies

51

Concerns related to the study center (e.g. the center was not a SFDA accredited center, the center was suspended by the SFDA, EMA or FDA)

23

Bioequivalence was not concluded

10

Design and conduct concerns:

6

 - Sub-optimal selection of the reference product

2

 - In appropriate selection of the lower limit of quantification

1

 - Sampling schedule/drug quantification did not cover a plasma concentration time curve long enough to calculate reliable estimates

1

 - The anticipated study condition (fast/fed) was not followed

2

 - Suboptimal analytical procedures

1

Quality concerns:

3

 - Concerns about the quality of active pharmaceutical ingredients

3

Regulatory concerns:

8

 - Rejection of a biowaiver submission

4

 - Non-compliance with the SFDA submission standards

3

 - The bioequivalence study was conducted for a strength that was not intended for SFDA registration

1