within subject stan­dard devi­ation in fully repli­cate design if carry over effect is pre­sent [General Sta­tis­tics]

posted by Ankit Parikh – India, 2023-06-08 15:54 (173 d 19:03 ago) – Posting: # 23582
Views: 1,120

How to calculate within subject standard deviation in fully replicate study design of carry over effect is present?

Eg. I am planning a full replicate single dose study in patients. Patients has to take medication at every 4 month. Pre-dose concentration in subsequent periods are observed below 5 % of Cmax or 0 in pilot study. If carryover effect is present in pivotal study but the pre-dose concentration is less than 5 % of Cmax, how should I calculate Swr for BE assessment?

After dosing, the plasma concentration reaches Cmax in about 4 hours and comes down below 5 % of Cmax in 2-3 days and remains stable from day 4 to 120 and is also the pre-dose concentration for subsequent period/s.

The primary PK parameters are Cmax, AUC0-t and AUC7-t

Thank you for your response in advance.

Edit: Category changed; see also this post #1[Helmut]

Complete thread:

UA Flag
 Admin contact
22,811 posts in 4,783 threads, 1,642 registered users;
14 visitors (0 registered, 14 guests [including 8 identified bots]).
Forum time: 09:58 CET (Europe/Vienna)

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

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