WinNonlin IVIVC Toolkit [Dissolution / BCS / IVIVC]

posted by Anu – India, 2013-07-29 14:21 (4706 d 02:31 ago) – Posting: # 11102
Views: 5,927

Hi John,

Thankyou very much for your additional comments.

❝ 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.


Though I have checked the Industrial Guidance for IVIVC as well IVIVC Guidance
On page no 6. It is written:
"Although an IVIVC can be defined with a minimum of two formulations with different release rates, three or more formulations with different release rates are recommended."
So kindly guide me how can I go about it?

My formulation is an Extended Release not IR.

❝ 2. Is your formulation an IR? If so, it maybe difficult to achieve IVIVC.


Thanks & Regards
Anu Jaswal

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