Bioequivalence and Bioavailability Forum • Pre dose concentration

Pre dose concentration [Regulatives / Guidelines]

posted by auditor – India, 2012-02-28 09:59 (5232 d 12:13 ago) – Posting: # 8173
Views: 12,097

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

Complete thread:

Pre dose concentrationauditor 2012-02-28 08:59
- Pre dose concentration drgunasakaran1 2012-02-28 11:36
- Read, Search ... d_labes 2012-02-28 12:03
  - Read, Search ... auditor 2012-02-28 12:08
    - Sorry d_labes 2012-02-28 12:49
    - Read, Search ... Helmut 2012-02-28 14:09
      - 5% Cmax rule and endogenous drugs - EMA d_labes 2012-02-28 16:40
        
        My interpretation + (lenghty) example Helmut 2012-02-28 17:18
        
        Well done! d_labes 2012-02-29 08:33
        
        Bad experiences… Helmut 2012-02-29 14:19