Validation of FDA's RSABE on NTIDs [RSABE / ABEL]

posted by yicaoting  – NanKing, China, 2017-08-22 20:01 (2224 d 05:43 ago) – Posting: # 17736
Views: 16,428

Dear Helmut,
Hope you are well.

I am trying to manually calculate the upper 90% CL of sWT/sWR in US FDA's RSABE for NTIDs(Draft Guidance on Warfarin).

I use BEBAC's sample data (page 14 of the PPT from this site) to validate/verify my calculation steps.

Data set link
http://bebac.at/downloads/NTID.xls

It will be greatly appreciated if you can help me on the following questions:
1. I manually calculate the sWR and sWT in Excel sheet, they are 0.124392769, 0.055720909, respectively. Are my results EXACTELY right?

2. In your slides, you have present the upper 95% CL of sWT/sWR 0.68427 ≤2.5.
I have calculated
lower 95% CL of sWT/sWR = 0.293238292
upper 95% CL of sWT/sWR = 0.684266753 (this is nearly the same as your result)

As US FDA's Guidance on Warfarin required, the upper 90% CI should be used, I also calculate the following:
lower 90% CL of sWT/sWR = 0.322597242
upper 90% CL of sWT/sWR = 0.621992961

Are the above results right?

I use the function Finv(0.1,16,16) and Finv(0.9,16,16) for the calculation of 90% CL of sWT/sWR,
and Finv(0.05,16,16) and Finv(0.95,16,16) for the calculation of 95% CL of sWT/sWR. Do I use the right function?

2. Would you please guide (step by step) me how to calculate CVwr CVwt? As shown in your slides, they are CVWR 12.49%, CVWT 5.58%. Although these two values are not used in calculation of "upper 90% CL of sWT/sWR".

Thank you for your great sample dataset which provides us a valuable bridge for us to learn and discuss this sparely used procedure.

Complete thread:

UA Flag
Activity
 Admin contact
22,759 posts in 4,775 threads, 1,627 registered users;
19 visitors (0 registered, 19 guests [including 7 identified bots]).
Forum time: 01:45 CEST (Europe/Vienna)

The only people who see the whole picture are the ones
who step out of the frame.    Salman Rushdie

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