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A role for ISOP in enabling specific population drug dosing recommendations


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.




Thanks Jack for the post and for testing the system.

I think that an organization like ISOP could play a major role in the steps you suggest. One might even say it is the responsibility of an organization like ISOP to be involved. In order for something like this to work, it needs to be designed from the start to be sustainable so that the community or consortia that supports it can live on past the delivery of Model 1.0. That’s the hard part for a non-commercially driven solution in my opinion.

An interesting approach was taken for ALS recently, where a crowd source solution was taken to developing a disease progression model. Prize4Life is a non-profit organization dedicated to the discovery of treatments and a cure for ALS and motor neurone disease. The organization uses the inducement prize contest model.

I am interested in what your thoughts are about what is the best way to develop, and probably equally important, maintain such models for specific dosing recommendations. I think we could envision multiple different sustainable types of “communities” to reach the goals 2-4, each with potential advantages and disadvantages.