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

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I am trying to manually calculate the upper 90% CL of sWT/sWR in US FDA's RSABE for NTIDs(Draft Guidance on Warfarin).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

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I am trying to manually calculate the upper 90% CL of sWT/sWR in US FDA's RSABE for NTIDs(Draft Guidance on Warfarin).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

- Validation of FDA's RSABE on NTIDsyicaoting 2017-08-22 18:01 [RSABE / ABEL]
- Validation of FDA's RSABE on NTIDs Helmut 2017-08-22 20:25
- Validation of FDA's RSABE on NTIDs yicaoting 2017-08-23 05:30
- Validation of FDA's RSABE on NTIDs Helmut 2017-08-23 15:00
- Validation of FDA's RSABE on NTIDs yicaoting 2017-08-30 14:33
- Validation of FDA's RSABE on NTIDs Helmut 2017-08-30 15:04

- Validation of FDA's RSABE on NTIDs yicaoting 2017-08-30 14:33

- Validation of FDA's RSABE on NTIDs Helmut 2017-08-23 15:00
- Clarification needed: Validation of FDA's RSABE on NTIDs CECIF 2018-02-19 22:20
- FDA's RSABE on NTIDs in R d_labes 2018-02-20 14:10
- FDA's RSABE on NTIDs in R CECIF 2018-03-01 21:08
- FDA's RSABE on NTIDs in R Helmut 2018-03-01 23:39

- FDA's RSABE on NTIDs in R CECIF 2018-03-01 21:08

- FDA's RSABE on NTIDs in R d_labes 2018-02-20 14:10

- Validation of FDA's RSABE on NTIDs yicaoting 2017-08-23 05:30

- Validation of FDA's RSABE on NTIDs Helmut 2017-08-22 20:25