Bioequivalence and Bioavailability Forum • Reference Scaled Design

rajneesh singh
☆

2011-06-13 12:14
(5085 d 14:23 ago)

Posting: # 7112
Views: 5,688

Reference Scaled Design [RSABE / ABEL]

Dear All,

Please any one suggest what are the main differences of Analysis for EMEA and USFDA Reference Scaled Study.

For USFDA, The 95% upper confidence bound for Square(YT -YR)-theta* within subject variability <=0
And the point estimate of the Test/Reference geometric mean ratio must fall within [0.80, 1.25]
For EMEA [U,L]= Exp[+/- k.swr] where k= 0.760,and swr = within subject variability of ln transformed of Cmax. CV % = 100*Exp(squre swr)-1 > 30% then our acceptance limit can be wide according to variability.

Is above main difference between USFDA and EMEA approach for reference scaled.

if else any other differences in approaches please suggest me. and how to do the analysis and any other criteria or any specification for regulatory also please suggest.

Thanks & Regards,
RS

Edit: Category changed. [Helmut]

GSTATS
☆

India,
2011-06-13 13:06
(5085 d 13:31 ago)

@ rajneesh singh
Posting: # 7113
Views: 4,754

Reference Scaled Design

Post reply

Dear RS,

❝ Please any one suggest what are the main differences of Analysis for EMEA and USFDA Reference Scaled Study.

I feel the main difference between the approaches recommended by EMA and FDA for reference scale study is the difference in regulatory constant used for scaling i.e For FDA swo=0.25 and for EMA swo=0.2936.

For complete disscussion on differences you should go through the thread given below:
Thread

Regards,
GSTATS

—
Let Noble Thoughts come from Every Side: RIG VEDA

rajneesh singh
☆

2011-06-17 11:41
(5081 d 14:56 ago)

@ GSTATS
Posting: # 7146
Views: 4,622

Reference Scaled Design

Post reply

Dear Gstat,

Please clarify, for reference Scale Design in USFDA submission :

Our BE criteria: Upper bound of 95% CI of (µT-µR)2 – θ σ2wr <= 0

Where θ = scaled average BE limit and θ = (ln Δ)2/ σ2wo Where σwo = 0.25

is that correct or not. :confused:

Thanks & Regards,
RS

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

GSTATS ☆ India, 2011-06-17 18:17 (5081 d 08:20 ago) @ rajneesh singh Posting: # 7151 Views: 4,648	Reference Scaled Design Post reply
	Dear RS, ❝ Our BE criteria: Upper bound of 95% CI of (µT-µR)2 – θ σ2wr <= 0 ❝ ❝ Where θ = scaled average BE limit and θ = (ln Δ)2/ σ2wo Where σwo = 0.25 ❝ ❝ is that correct or not. Yes, that is correct. Regards, GSTATS www.gstatsolutions.com — Let Noble Thoughts come from Every Side: RIG VEDA