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gsrao2022 ☆ India, 2026-01-16 17:21 (158 d 09:34 ago) Posting: # 24548 Views: 1,477 |
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As per the USFDA Draft guidance Venetoclax film-coated tablets requires two studies Fasting and Fed studies. is same number of studies required for Europe submission as the Both the regulatories following M13 A guidelines. why this product requires 2 studies. Draft Guidance link: https://www.accessdata.fda.gov/drugsatfda_docs/psg/Venetoclax_oral%20tablet_RLD%20208573_RC03-17.pdf Please give me your views. |
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A.Shtaiwi ☆ Jordan, 2026-02-02 09:46 (141 d 17:09 ago) @ gsrao2022 Posting: # 24562 Views: 1,019 |
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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 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] |
Ing. Helmut Schütz