strange question: An RLD (RS) which can be scored [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2022-09-14 19:25 (80 d 18:25 ago) – Posting: # 23294
Views: 419

(edited by wienui on 2022-09-15 12:09)

Hi John,

❝ A strange question... for FDA (Or anywhere else), if a RS or RLD product is scorable (100 mg, scored into 2 50 mg), can one file an ANDA for a 50 mg generic by comparing 2x50 mg vs the scorable 100 mg reference? My initial guess is no but strange things do happen...


Scientifically it is possible, and regulatory-wise, I didn't see any problem because, as you know, in BE, the dose of the test and reference drug formulation must be the same, which is applicable here.
Moreover, the guidelines asked for scored tablets to be tested through in vitro comparative dissolution against the whole tablets ( 2half vs the whole one); why not this also be applied in vivo?

Cheers,
Osama

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