Bioequivalence and Bioavailability Forum

Read, Search ... [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2012-02-28 13:03 (4440 d 05:51 ago) – Posting: # 8176
Views: 8,334

Dear Auditor,

did you read the FDA guidances?

Guidance for Industry
"Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations" 2003
page 25 of 26
Heading "Subjects with predose plasma concentrations:"

Or search the Forum and you would find this post and others.

Complete thread:

• Pre dose concentration auditor 2012-02-28 08:59 [Regulatives / Guidelines] 
  • 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