Different products → different BA [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-08-17 17:36 (924 d 12:14 ago) – Posting: # 22523
Views: 2,048

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
 Admin contact
22,912 posts in 4,806 threads, 1,636 registered users;
28 visitors (0 registered, 28 guests [including 5 identified bots]).
Forum time: 04:51 CET (Europe/Vienna)

Exploratory analysis: The art of finding a Rembrandt
in a Jackson Pollock.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz