Any own thoughts? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-06-18 08:59 (864 d 05:13 ago) – Posting: # 18914
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Hi Ramesh,

» As per guidelines, Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation.
» Is it applicable for endogenous molecule?

All your posts are in the category Regulatives / Guidelines.
Remember that our job is not exegesis but science. Hence, what do you think?

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Helmut Schütz
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