Bioequivalence and Bioavailability Forum

Dear Unique One,

Please find below response for your reference.

❝ 1. Can we proceed with the pivotal study by considering the above results of pilot study?

Response: Yes, you can proceed for Pivotal BE study.

❝ 2. Cmax and AUC inf are showing ISCV above 30%. Therefore what could be the conclusion for same?

Response: It depends not limited to Physiological conditions to subjects, formulation excipients, in-vitro release, nature of drug etc...

❝ 3. As per the ratios of test/reference, are their any evaluations required with respect to formulation.

Response: Two Crossover design: For considering Cmax ISCV 43.13 sample size required 62 subjects, additionally considered 6 subjects for drop-out & withdrawal. Total 68 subjects.

Partial Replicate: 24 subjects

❝ 4. There are 2 subjects data out of 14 in which the concentration data is quite anomalous and not matching with the rest of the 14 subjects data. Would this be the reason for higher ISCV of Cmax and AUC Inf?

Response: May be.. you can exclude these 2 subjects and run the data & find T/R Ratio, ISCV. Based on that you can conclude.

❝ 5. If we go by considering the above results for pivotal, what could be the design and an approximate sample size?

Response: Please refer Question 3 Response.

Let me know further clarification required,
Regards,
A.Anand,
Asst.Manager,
Bio-Pharmaceutics & Pharmacokinetics(Bio-PK/CPPK)
India

---

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]