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Registerwithin 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 (553 d 00:47 ago) – Posting: # 23582
Views: 2,993
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]
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:
- within subject standard deviation in fully replicate design if carry over effect is presentAnkit Parikh 2023-06-08 13:54 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-08 16:35
- within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-09 07:15
- within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-14 09:26
- within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-14 09:33
- within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-14 10:37
- within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-14 09:33
- within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-14 09:26
- within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-09 07:15
- within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-08 16:35
Ing. Helmut Schütz