Bioequivalence and Bioavailability Forum

Hi gsrao;

I think two studies are required: one under fasting conditions and one under fed conditions. The product is BCS Class IV and the reference product uses a solid dispersion approach during manufacturing. As mentioned in the originator assessment report, venetoclax is an ionisable compound with very poor aqueous solubility, and a solid dispersion in copovidone is used to enhance its apparent solubility and bioavailability.

According to ICH M13A, products with low solubility and complex formulation or manufacturing approaches, such as solid dispersions, are considered high-risk products. Therefore, both fasting and fed bioequivalence studies are necessary for EMA submission

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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! [Ohlbe]