Biostats
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India,
2018-03-29 12:39
(1345 d 04:55 ago)

Posting: # 18613
Views: 5,527
 

 bioequivalence criteria for NTID [Regulatives / Guidelines]

Dear All,

As per Draft Guidance on Warfarin Sodium bioequivalence criteria for NTID as
  1. Every study should pass the scaled average bioequivalence limits and
  2. Also regular unscaled bioequivalence limits of 80.00-125.00%.
  3. the upper limit of the 90% equal-tails confidence interval for σwT/σwR is less than or equal to 2.5
My understanding for 1 and 2 criteria as below,
  1. The 95% upper confidence bound for (YTYR)2θs2wR must be ≤ 0 and the point estimate of the Test/Reference geometric mean ratio must fall within 80.00 – 125.00%. (scaled average bioequivalence limits)
  2. 90% confidence interval should lies within 80–125% (unscaled bioequivalence limits)
Is this correct? Please guide me to understand the bioequivalence criteria of NTI drugs.

Thanks in advanced.
Helmut
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Vienna, Austria,
2018-03-29 14:27
(1345 d 03:07 ago)

@ Biostats
Posting: # 18615
Views: 4,377
 

 bioequivalence criteria for NTID

Hi Biostats,

your understanding of 1 & 2 is correct. Don’t forget #3!

» Please guide me to understand the bioequivalence criteria of NTI drugs.

Can you be more specific?

Dif-tor heh smusma 🖖
Helmut Schütz
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Biostats
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India,
2018-03-30 06:25
(1344 d 11:09 ago)

@ Helmut
Posting: # 18623
Views: 4,254
 

 bioequivalence criteria for NTID

Thanks Sir,

Is it mandatory to check - point estimate of the Test/Reference geometric mean ratio must fall within 80.00 - 125.00%?


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
Helmut
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Vienna, Austria,
2018-03-30 11:19
(1344 d 06:15 ago)

@ Biostats
Posting: # 18624
Views: 4,423
 

 GMR not relevant in ABE

Hi Biostats

» Is it mandatory to check - point estimate of the Test/Reference geometric mean ratio must fall within 80.00 - 125.00%?

See your condition #2 and the guidance

Every study should pass the scaled average bioequivalence limits and also regular unscaled bioequivalence limits of 80.00–125.00%.


What do you think where the GMR lies if a study passes ABE? It is only nice to know (unless you are concerned about this discussion). If a study fails ABE, the location of the GMR is even less relevant. Hence, the FDA does not ask for it.

Dif-tor heh smusma 🖖
Helmut Schütz
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arl_stat
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India,
2020-10-15 16:12
(414 d 01:22 ago)

@ Helmut
Posting: # 22010
Views: 1,050
 

 Presentation of data in report and SAS output

Dear All,

Greetings !!

FDA recommends not to round off the decimal places for confidence intervals.
So for NTI drugs, the Swt, Swr and 95% upper bound and point estimate should be presented upto 2 decimal places without rounding off.

If for Cmax, the 95% upper bound value is 0.0025 and if presented as 0.00, will the study can be considered as pass?

For analysis in SAS, should we present the values in 2 decimals or 4 decimals without rounding off?

As in above criteria, if we present the data in 2 decimal places, the study is pass.

Please guide.

Thanks:-)
jag009
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NJ,
2018-03-29 17:20
(1345 d 00:14 ago)

@ Biostats
Posting: # 18618
Views: 4,309
 

 bioequivalence criteria for NTID

» Please guide me to understand the bioequivalence criteria of NTI drugs.

This might help. A nice article from my professor...

Endrenyi - NTI

John
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