WinNonlin IVIVC Toolkit [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2013-07-26 17:31 (4712 d 07:59 ago) – Posting: # 11064
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Hi,

❝ Since %PE for AUC_last is <10% and not for Cmax.

❝ Does that mean IVIVC is not established?


Correct.

Additional comments:
  1. An IVIVC should have 3 formulations (it takes 3 pts to do a correlation, 3=fast, target (medium), slow formulations). You only have 2.
  2. Is your formulation an IR? If so, it maybe difficult to achieve IVIVC.
  3. Depending on the solubility and permeability of the drug, it might not be possible to do an IVIVC (Refer to BCS classification).

Hope this helps.

John

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