Hi! One of my clients received an interesting question from a European authority… BE studies were performed on 2mg and 4mg strengths, but due to safety reasons the 8mg strength was only tested in steady state after a run-in period (unethical to adminster a 8mg dose due to AEs). The schedule was (once a day dosing): two days of 2mg, two days of 4mg, two days of 6mg, and five days of 8mg. On day 12 formulations were switched and dosed for another five days. BE assessment was performed comparing day 11 and 16 profiles. Now the authority asked for MD simulations based on the 2mg and 4mg single dose studies and a comparison of simulated MD profiles with the 8mg profile as the reference. So far, so bad. One remark and the nasty question: [ul][li]In setting up the NPSP I sort by subject and treatment and have only the possibility to set period and sequence to none. It would be nice to have another column in order to carry over these variables to the simulation in order to perform a BE assessment on the profile days. Right now I have to merge the results to the randomization.[/li][li]Any ideas how to set up the NPSP for the given administration schedule? Product A in the run-in until the first profile and the the switch-over to product B (and vice versa)?[/li][/ul]
Hi Helmut, for your information we do have an enhancement about carry alongs logged (QC 9864), however I can’t say when it would be implemented at this time.. " * Any ideas how to set up the NPSP for the given administration schedule? Product A in the run-in until the first profile and the the switch-over to product B (and vice versa)?" I found it a little tricky to visualize your exact workflow, so if you can it would be interesting to receive the project so we can review your existing steps and see if we can suggest a more optimal workaround in the meantime. Simon. PS - I asked around and we don’t seem to have any documented issues like your screen resolution problems so I’ve opened the attached poll, to see if we can find out some common source of the issue. Certara | Drug Development Solutions