Helmut
★★★
avatar
Homepage
Vienna, Austria,
2020-09-28 17:12
(431 d 01:24 ago)

Posting: # 21947
Views: 957
 

 ABEL: Type I Error [RSABE / ABEL]

Dear all,

we know for a good while that under certain conditions the Type I Error (TIE) might be inflated. However, seemingly European assessors were either not aware of it or ignored it. Last week I saw a deficiency letter (don’t ask for the country):

… in case of a value of 30% < CVRR <45%, it is recommended to check the control of the patient's risk type I error at the level of 5%. If an alpha adjustment is necessary, it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds.


Kudos! Almost correct. The area of inflated TIEs may reach below 30% and only rarely (say, for a 4-period full replicate in 24 subjects) to 45%.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
d_labes
★★★

Berlin, Germany,
2020-09-28 17:51
(431 d 00:45 ago)

@ Helmut
Posting: # 21948
Views: 797
 

 Wow!

Dear Helmut!

» we know for a good while that under certain conditions the Type I Error (TIE) might be inflated. However, seemingly European assessors were either not aware of it or ignored it. Last week I saw a deficiency letter (don’t ask for the country):

… in case of a value of 30% < CVRR <45%, it is recommended to check the control of the patient's risk type I error at the level of 5%. If an alpha adjustment is necessary, it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds.


» Kudos! Almost correct. The area of inflated TIEs may reach below 30% and only rarely (say, for a 4-period full replicate in 24 subjects) to 45%.

Can say only: Wow! :clap:

Regards,

Detlew
ElMaestro
★★★

Denmark,
2020-09-29 10:41
(430 d 07:56 ago)

@ Helmut
Posting: # 21949
Views: 763
 

 ABEL: Type I Error

» .... (don’t ask for the country):

… in case of a value of 30% < CVRR <45%, it is recommended to check the control of the patient's risk type I error at the level of 5%. If an alpha adjustment is necessary, it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds.


That subjunction is correct but not part of the everyday linguistic toolbox of those who do not speak a lot of English. My guess is MHRA or the Irish Medicines Board or it comes from someone who spent a lot of time taking English language classes :-)

Pass or fail!
ElMaestro
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2020-09-29 10:49
(430 d 07:47 ago)

@ ElMaestro
Posting: # 21950
Views: 753
 

 Lost in translation

Hi ElMastro,

» »

… it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds.


» That subjunction is correct but not part of the everyday linguistic toolbox of those who do not speak a lot of English. My guess is MHRA or the Irish Medicines Board or it comes from someone who spent a lot of time taking English language classes :-)

Not quite. :-D
Just before the mentioned text it read:

… no confirmation is provided that variability in the reference drug exists and is not caused by emissions; please provide confirmation in the form of an emissions estimate.

We guessed that outliers were meant by “emissions”.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 8 (0 registered, 8 guests [including 5 identified bots]).
Forum time: Friday 17:37 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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