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

posted by Ramesh Ramalingam – India, 2018-06-18 10:00 (2135 d 23:12 ago) – Posting: # 18913
Views: 3,866

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

Complete thread:

> 5% of Cmax for endogenous molecule?Ramesh Ramalingam 2018-06-18 08:00
- Any own thoughts? Helmut 2018-06-18 10:59
  - carryover effect in endogenous substances Ramesh Ramalingam 2018-08-08 07:29

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