Bioequivalence and Bioavailability Forum • 2-period full replicate design for IR formulation

2-period full replicate design for IR formulation – EMA perspective [Regulatives / Guidelines]

posted by BEQool – 2025-03-01 13:33 (109 d 15:00 ago) – Posting: # 24378
Views: 1,284

Dear Ankit Parikh,

❝ Question: To address the challenges related to retention of cancer patients in PK BE study, we want to plan 2-period full replicate design. Will the EMA accept this approach for Immediate Release (IR) formulation?

Do you mean 2-period or 4-period design? I.e., do you mean 2 PK days (once T and once R) or 4 PK days (twice T and twice R)?

❝ So, based on our interpretation this will be TTRR or RRTT design.

Did you then use this 4-period replicate desing with 4 PK days?

❝ As per the published EMA Public Assessment Report (EPARs), there are few products approved by EMA using this approach such as Bupropion and Felodipine modified release formulations.

I was looking for these EPARs but could not find them. Could you please share them?

Best regrads
BEQool

Complete thread:

2-period full replicate design for IR formulation – EMA perspective Ankit Parikh 2024-07-11 04:58 [Regulatives / Guidelines]
- 2-period full replicate design for IR formulation – EMA perspectiveBEQool 2025-03-01 12:33