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Back to the forum  2018-07-22 07:47 CEST (UTC+2h)
Luongnv
Junior

Vietnam,
2018-02-22 07:35

Posting: # 18443
Views: 686
 

 BE waiver for proportional formula [Regulatives / Guidelines]

Hi all,

I tried to look for similar discussion but none found.

We are developing a formula (let's say, 40mg) and intend to waiver the BE for 20mg dosage form. The two formulae are proportional. However, the innovator 40mg and 20mg formulae are different in terms of inactives.

Dissolution of respective formula is similar with f2>85.

Is it acceptable if we apply BE waiver for the low dose?

Please pass your comments.

Thanks and regards

Luong (Mr.)
m.ross
Junior

Switzerland,
2018-03-15 12:11

@ Luongnv
Posting: # 18553
Views: 312
 

 BE waiver for proportional formula

The proportional waiver is for your product and not for the reference. Assuming that there is nothing strange in the labelling of the reference indicating that their two doses are not equivalent (like a statement that 2 x 20mg is not equivalent to 1 x 40mg) then there should be no issue.


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. Please follow the Forum’s Policy[Helmut]
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