Bioequivalence and Bioavailability Forum

Different products → different BA [Study Assessment]

posted by Helmut – Vienna, Austria, 2021-08-17 17:36 (1244 d 13:00 ago) – Posting: # 22523
Views: 3,484

Hi Mehul,

❝ ❝ 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%.

OK, that’s another cup of tea. If you had different test products (not batches of the same one) in the studies, it’s not uncommon they differ. Were these modified release products? For them similar AUC and different C_max is much more common than for IR products.

❝ What may be the reasons for this?

Different products, different bioavailability… Business as usual.

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Helmut Schütz

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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 product Mehul Patel 2021-08-17 12:02
    - Different products → different BAHelmut 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

Different products → different BA [Study As­sess­ment]

Complete thread:

Different products → different BA [Study Assessment]