Biowaiver for Lower Strength [Regulatives / Guidelines]

posted by vandee – Malaysia, 2020-11-25 07:21 (732 d 01:53 ago) – Posting: # 22083
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❝ The FDA doesn't consider this 5% rule and the requirements for an additional strength biowaiver are as following:


❝ – Total weight of dosage form nearly the same for all strengths

❝ – Same inactive ingredients in each strength

❝ – Change in strength obtained by varying active and one or more inactive ingredients


❝ Both EMA & FDA are asking for the Similarity of dissolution characteristics of the biowaiver strength to the strength for which bioequivalence has been demonstrated in vivo.


Dear Osama,
This is indeed very helpful. I will justify my biowaiver using the USFDA approach in hopes that regulators here (ASEAN) will accept. Thank you very much for your advise.


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[Helmut]

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