Hi, I have a question regarding the UIR generation step in the IVIVC model. Here is my scenario (hypothetical). 1) I have 4 ER formulation dissolution and plasma profiles. One of them is a target formulation 2) I have a immediate release profile (normallized to the same dose as the ER formulations). The AUC of the IR is normalized to that of the target formulation as well. 3) All plasma (ER and IR) profiles are adequately sampled (i.e., AUClast/AUCinf >= 0.99) 4) I proceed with IVIVC and continue to the step where UIR is being generated from the IR data Question: When the UIR is generated from the IR data via fitting/modeling, does the IVIVC program also make adjustment so that the resulting UIR profile still has the same AUC as the target formulation? This will ensure the next step → Deconvolution will give a complete absorption profile (100%. Correct me if I am wrong in this thinking) I hope my question is clear. Thanks John
John, perhaps I am misunderstanding your question but no we don’t ‘correct’ the UIR to get 1005 absorbtion - the deconvolution uses the % absorbtion observed. 100% absorbtion can’t be assumed because of Bioavailablilty etc. Simon.
Hi Simon, Sorry for the late response. Let me rephrase it a bit. Scenario: 1) You are using a IR product (Not IV) to as serve as UIR to deconvolve a MR product 2) The IR product data is not from the same study, but rather from literature data 3) The MR product is designed to be bioequivalent to the IR product given multiple times daily (example, b.i.d.) In the above scenario, shouldn’t you correct the UIR to have similar AUC as the MR so that the deconvolved % absorbed profile plateaus at 100%? This is just an experimental idea… Thanks John