Bioequivalence and Bioavailability Forum • Significant difference in Cmax of Reference drug product

Significant difference in Cmax of Reference drug product [Study Assessment]

posted by dshah – India/United Kingdom, 2021-08-21 10:48 (357 d 16:00 ago) – Posting: # 22530
Views: 1,156

Dear Méhul!
There can be multiple reasons for the same.

Same subjects? With subject changes- concentration also changes a bit.
Same BA method?
Same Internal standard batch? Change in internal standard changes height and thus ultimately concentration.

Regards,
Dshah

Complete thread:

Significant difference in Cmax of Reference drug product Mehul Patel 2021-08-17 10:00 [Study Assessment]
- Significant difference in Cmax of Reference drug product Helmut 2021-08-17 11:57
  - Significant difference in Cmax of Reference drug product Mehul Patel 2021-08-17 12:02
    - Different products → different BA Helmut 2021-08-17 15:36
    - Significant difference in Cmax of Reference drug productdshah 2021-08-21 10:48
      - Reasons? Helmut 2021-08-21 21:43
        
        Reasons? dshah 2021-08-24 12:06

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