Bioequivalence and Bioavailability Forum • Replicated design for a combination [Highly variable+Normal]

Replicated design for a combination [Highly variable+Normal] [Design Issues]

posted by Dr_Dan – Germany, 2013-06-19 14:04 (4753 d 18:44 ago) – Posting: # 10816
Views: 5,206

Dear Naveen Kumar.SR

The intra-CV of Valsartan is slightly above 30% ⇒ HVD, so it could make sense to use a replicate design in order to allow widening of the acceptance range for this component (valsartan only) of the combinationproduct. However, you need to keep the following in mind:

Valsartan and amlodipin differ very much in PK profile ⇒ two different sampling schemes = many blood samples, too much for replicate design?
Amlodipin has a long elimination half life (35-50 h) ⇒ you need a two weeks wash-out phase which is not very helpful for a replicate design study.
A truncated AUC is possible but would not solve the problems mentioned above.

I hope this helps
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Replicated design for a combination [Highly variable+Normal] Naveen Kumar 2013-06-17 14:37
- Replicated design for a combination [Highly variable+Normal] jag009 2013-06-17 17:24
  - Replicated design for a combination [Highly variable+Normal] Naveen Kumar 2013-06-18 14:53
    - Replicated design for a combination [Highly variable+Normal]Dr_Dan 2013-06-19 12:04
      - Replicated design for a combination [Highly variable+Normal] Naveen Kumar 2013-06-21 05:19