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.)
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.)
Complete thread:
- BE waiver for proportional formulaLuongnv 2018-02-22 07:35 [Regulatives / Guidelines]
- BE waiver for proportional formula m.ross 2018-03-15 12:11