suchit_bhavsar
★    

India,
2017-04-24 09:29
(2530 d 21:50 ago)

Posting: # 17255
Views: 3,385
 

 Regarding Statistical criteria for BE study of anticoagulant molecule [Regulatives / Guidelines]

Dear All,

Can you plz tell me the Statistical criteria to be kept for BE study of Anticoagulant molecule having steep exposure response relationship for both safety and efficacy for canada submission.
Can i follow OGD for BE study conducted for Canada submission?:confused:

Tnx & Regards,
Nirav
d_labes
★★★

Berlin, Germany,
2017-04-24 13:26
(2530 d 17:54 ago)

@ suchit_bhavsar
Posting: # 17256
Views: 2,910
 

 Critical dose drugs

Dear Nirav,

❝ Can you plz tell me the Statistical criteria to be kept for BE study of Anticoagulant molecule having steep exposure response relationship for both safety and efficacy for canada submission.

❝ Can i follow OGD for BE study conducted for Canada submission?:confused:


If you aimed for a submission in Canada I think the
"Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects"
paragraph 2.1.1.6 Critical dose drugs
applies.

Hope this helps.

Regards,

Detlew
suchit_bhavsar
★    

India,
2017-04-24 14:04
(2530 d 17:16 ago)

@ d_labes
Posting: # 17257
Views: 3,022
 

 Critical dose drugs

❝ If you aimed for a submission in Canada I think the

❝ "Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects" paragraph 2.1.1.6 Critical dose drugs applies.


Thnx a lot for your reply.
As per "Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects" paragraph 2.1.1.6 Critical dose drugs gives criteria of NTI drugs.
Actually for molecule like rivaroxaban(Anticoagulant) its OGD says that,
Applicants should use the average BE approach with BE limits of 80-125%. The within-subject variability of test (T) and reference (R) products should be compared, and the upper limit of the 90% confidence interval for the test-to-reference ratio of the within-subject variability should be ≤ 2.5.

So, should i use "Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects" paragraph 2.1.1.6 Critical dose drugs?:-)

Regards,
Nirav


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]
d_labes
★★★

Berlin, Germany,
2017-04-25 10:41
(2529 d 20:38 ago)

@ suchit_bhavsar
Posting: # 17260
Views: 3,014
 

 Critical dose drugs - FDA highly variable NTID

Dear Nirav,

again: If you aimed a submission in Canada follow my hint.

What you cite as "OGD for rivaroxaban" is FDA recommended evaluation method. Follow it if you aim for an FDA submission.

If you aim for an EMA submission follow the EMA recommendations.

Other regulatory bodies may have different recommendations. Follow them if you aim for a submission to them.

Simple. Isn't it?

Regards,

Detlew
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