Question

Which of the following levels of IVIVC is represented by “the relatinship between one dissolution time point(e.g., t 50%) and one mean pharmacokinetic parameter, such as AUC, T_max or C_max”?

• A. Level A
• B. Level B
• C. Level C
• D. Level D

Answer 1

The Correct Option is C

The question tests your understanding of the different levels of In Vitro-In Vivo Correlation (IVIVC), specifically asking which level correlates a single dissolution time point with one mean pharmacokinetic parameter. Let's examine the options:

1. Level A: This is the highest level of IVIVC correlation, where there is a direct point-to-point relationship between in vitro dissolution and in vivo input rates (pharmacokinetic parameters). It is not confined to a single point comparison but rather across the entire profile.
2. Level B: This level focuses on the statistical moment analysis. It involves comparing the mean in vitro dissolution time to a single mean pharmacokinetic parameter, such as the mean residence time (MRT). This approach is more generalized than Level C.
3. Level C: This level establishes a single point of correlation between a dissolution time point (e.g., time required to dissolve 50% of the drug, t_50%) and a mean pharmacokinetic parameter (such as AUC, T_max, or C_max). It is a straightforward comparison that does not characterize the entire absorption curve.
4. Level D: This is not a recognized level of IVIVC. The typical classifications are Levels A, B, and C.

Given the descriptions, the correct answer is indeed Level C, as it pertains to the correlation between a specific dissolution time point and a single mean pharmacokinetic parameter.

Therefore, the correct option is: Level C.