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RegisterEndogenous NTI drugs [Regulatives / Guidelines]
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
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
Complete thread:
- Endogenous NTI drugsNK 2018-09-19 07:31 [Regulatives / Guidelines]
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Ing. Helmut Schütz