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 (412 d 10:59 ago) – Posting: # 23582
Views: 2,250

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
Activity
 Admin contact
23,127 posts in 4,859 threads, 1,646 registered users;
37 visitors (0 registered, 37 guests [including 7 identified bots]).
Forum time: 02:54 CEST (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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