FDC or isomers: C0 > 5 % of Cmax [Regulatives / Guidelines]

posted by Achievwin – US, 2024-08-05 21:08 (284 d 07:15 ago) – Posting: # 24134
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❝ The ICH’s M13A will soon supersed the FDA’s guidance. However, a similar procedure is stated in its Section 2.2.3.3 Carry over.


❝ The idea of assessing the predose concentrations in higher period(s) is to check whether the washout was sufficiently long. The treatment comparison in the presence of equal/unequal carryover would – unavoidably – be biased and there is no statistical method to adjust for it.


Oh my equal/unequal carryover – never ending story

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