> 5% of Cmax for endogenous molecule? [Regulatives / Guidelines]

posted by Ramesh Ramalingam  – India, 2018-06-18 06:00 (1094 d 01:18 ago) – Posting: # 18913
Views: 2,917

Dear All,

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? could you please suggest anyone..



Regards,
Ramesh. R

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