BE waiver for proportional formula [Regulatives / Guidelines]

posted by Luongnv – Vietnam, 2018-02-22 07:35  – Posting: # 18443
Views: 1,629

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.)

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