Biowaiver for Lower Strength [Regulatives / Guidelines]
❝ 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.
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]