Bioequivalence and Bioavailability Forum • FDA: Biowaiver for other strengths

jag009
★★★

NJ,
2012-04-17 21:55
(5187 d 13:34 ago)

Posting: # 8436
Views: 3,486

FDA: Biowaiver for other strengths [Regulatives / Guidelines]

Hi everyone,

For a generic product, can a biowaiver be filed for lower strengths AND upper strengths? If I have a generic product and the RLD is not the highest strength, can a biowaiver be filed for the highest strength? That is to do BE studies on the lower strength and claim biowaiver on higher strenghts since the strengths are dosage form proportional and similar in-vitro. Is this allowed due to safety reasons or simply because the RLD at highest strength is not available?

Thanks

John

Dr_Dan
★★

Germany,
2012-04-19 18:32
(5185 d 16:57 ago)

@ jag009
Posting: # 8447
Views: 2,948

FDA: Biowaiver for other strengths

Post reply

Hi John
In order to transfer the whole information on pharmaco-toxicological and clinical experience from the originator product to the Test product the Test product has to be considered identical in dose, strength, route of administration, safety, efficacy, and intended use. If the RLD is not the highest strength, no biowaiver can be filed for the highest strength even if the strengths are dosage form proportional and similar in-vitro.
Kind regards
Dan

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Kind regards and have a nice day
Dr_Dan