A recent article in JCP outlined a possible paradigm for the use of modeling and simulation to provide information for drug labeling (see: A proposal for scientific framework enabling specific population drug dosing recommendations). This is being considered as a possible IMI project.
Renal and hepatic impairment are being considered as two initial specific populations to help build a generalized procedure for all specific populations. The idea is to first collect information from as many previous human trials and pair this data with other compound and system (i.e. biologic) data needed to predict the pharmacokinetics of a new molecule in these specific populations. If the molecules are sufficiently predictive (yet to be defined), one could envision a host of possible regulatory pathways up to and including (if highly predictive) never running a clinical study (e.g. this might be one way to get dosing recommendations for unstudied specific populations, like burn patients into a label).
The project has a series of deliverables that need to be undertaken in order to be successful:
Deliverable 1: Knowledge management
Deliverable 2: Models for clearance pathway for each specific population
Deliverable 3: Model qualification
Deliverable 4: Applicability domain
Deliverable 5: Regulatory
So, here is where ISOP comes in … It would seem that the ISOP community could have a major role in Deliverables 2-4. For instance, ISOP members might take on development and improvement of models. There might be a role of ISOP in helping to determine what qualification would look like as well as deciding whether or not improvements were sufficient to be incorporated into a supported model.
My question is, what would make this of sufficient interest to have a community of active users?
For those interested in being active in such a project right now, please don’t hesitate to contact me. I can share the current 2 page document further outlining the proposal.