Bioequivalence and Bioavailability Forum

Dear Pankaj!

❝ I was aware of both Parallel and Truncated design individually. But wasn't

❝ sure whether I can club Parallel with truncation model since it is not

❝ clearly mentioned in the guidelines.

Ok, let's say it the other way 'round. Why did you think that one may not combine a parallel design with truncated AUC? I would say it's important to comprehend the 'sprit' (if any) behind guidelines and not to search all the time for a 100 % literally match with you intended design. The main reasons for a parallel design are quite clearly stated in GLs and I don't repeat them here. Truncated AUC helps in preventing drop-outs due to long sampling (or just missing samples). One might even get a better estimate of C_max, since with the savings in budget, more frequent sampling in the earlier part of the profile becomes affordable.