Different products → different BA [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-08-17 17:36 (527 d 12:26 ago) – Posting: # 22523
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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 Cmax 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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