Pre dose concentration [Regulatives / Guidelines]

posted by auditor – India, 2012-02-28 08:59 (3615 d 12:07 ago) – Posting: # 8173
Views: 8,320

Dear All,

As per recent EU guideline for BA/BE, clear statement given for not to withdraw any subject in which >5% Cmax concentration observed after dosing endogenous molecule.

I am looking for such kind of clarity in US FDA guidance. Can any one please let me know is the same thing can be followed in US submission?

Regards,

Auditor

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