Endogenous NTI drugs [Regulatives / Guidelines]

posted by NK – India, 2018-09-19 07:31 (1125 d 14:11 ago) – Posting: # 19292
Views: 1,132

Dear All,

Whether below mentioned statement will be applied to drug categorized as endogenous & NTI drugs?

"baseline-adjusted pre-dose concentrations (at time 0 hour) greater than 5% of their Cmax should be excluded from the bioequivalence statistical analysis"

Regards
NK

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