Risking Refuse-to-Receive [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-03-28 11:25 (1301 d 05:46 ago) – Posting: # 18599
Views: 2,560

Hi sudy,

» […] can we use RSABE approach in case if we get ISCV-reference > 30% for any one of the PK parameter Cmax or partial AUCs, instead of using 90% CI calculation to prove the bioequivalence?

The guidance clearly states:

The 90% confidence intervals of the geometric mean test/reference (T/R) ratios for the above five Cmax and AUC metrics (Cmax, AUC0-T1, AUCT1-T2, AUCT2-T3, AUC0-∞) should fall within the limits of 80-125%.


Without a controlled correspondence you will risk an RTR because according to

» The OGD recommendation did not discuss anything about this case, as we know that methylphenidate is not a HVD.

In my experience you will get the highest CV in the first partial AUC of the fasting study. I never saw a high CV of Cmax… A CVwR >30% of AUC0-3 is extremely unlikely.

@John: Other experiences?

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,742 posts in 4,546 threads, 1,543 registered users;
online 10 (1 registered, 9 guests [including 5 identified bots]).
Forum time: Tuesday 17:12 CEST (Europe/Vienna)

Sometimes the key to an answer is found
in the way you formulate the question.    David Brin

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5