Risking Refuse-to-Receive [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-03-28 13:25 (2192 d 15:07 ago) – Posting: # 18599
Views: 2,955

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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
84 visitors (0 registered, 84 guests [including 7 identified bots]).
Forum time: 03:33 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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