Fig. 4.

Outcome of the review of 64 RSABE studies reviewed at the OGD. All but two of the studies met the BE acceptance criteria. For 36 of these studies, there were no other deficiencies related to the BE portion of the ANDA submission. For 26 studies, other miscellaneous deficiencies unrelated to RSABE analysis (most often related to the bioanalytical method used) were present in the BE portion of the submission. One study did not meet the point estimate constraint and thus the study did not meet the RSABE acceptance criteria. Another study could not be analyzed using RSABE because the s _WR for C _max was <0.294. However, when the TOST was applied, the 90% CI for C _max did not fall within the 80–125 limits; thus, this study did not meet the ABE acceptance criteria