Bioequivalence and Bioavailability Forum

Significant difference in Cmax of Reference drug product [Study Assessment]

posted by Mehul Patel – India, 2021-08-17 14:02 (1772 d 09:25 ago) – Posting: # 22522
Views: 6,359

❝ I guess you had also the same batch of the test? Was the AUC different as well?

Both the tests were different but Reference were same. AUC of Reference was similar for both the studies, only Cmax varied by 22%. What may be the reasons for this?

❝ ❝ […] Can 6 months old (frozen) samples yield significant different results as compared to freshly analyzed study samples?

❝

❝ If long term storage was validated for this duration, no.

Ok. Thanks

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 #5! [Helmut]

Complete thread:

Significant difference in Cmax of Reference drug product Mehul Patel 2021-08-17 10:00 [Study Assessment]
- Significant difference in Cmax of Reference drug product Helmut 2021-08-17 11:57
  - Significant difference in Cmax of Reference drug productMehul Patel 2021-08-17 12:02
    - Different products → different BA Helmut 2021-08-17 15:36
    - Significant difference in Cmax of Reference drug product dshah 2021-08-21 10:48
      - Reasons? Helmut 2021-08-21 21:43
        
        Reasons? dshah 2021-08-24 12:06

Significant difference in Cmax of Reference drug product [Study As­sess­ment]

Complete thread:

Significant difference in Cmax of Reference drug product [Study Assessment]