Challenge - something for the programmers here [Bioanalytics]
❝ 1 / Are there any references to follow, or does it really depend on the nature of the molecule to be studied?
❝ 2 / Are there any precautions or recommendations to consider?
One thing that occasionally crossed my mind was that I would love to see someone (no, I am of course not naming anyone and of course I do not have any particular person in mind, Helmut ) writing a function in R which takes some arguments of relevance and spits out a list of proposed sampling points.
Arguments might include anything known or anticipated about dose, half-life, lag time, expected Cmax, LLOQ, and so forth.
Obviously there could be a lot of ifs and buts and unknowns. But still something useful might be produced. Some arguments might be missing and then the function could highlight implied assumptions however wrong they might in reality be. Things like convenience could be factored in (for example, you don't want to wake of the volunteer at 4:30 am unless it is really necessary).
Here's a Valsartan SPC.
Here's a Valsartan PAR.
Let's just say I have an assay that I think has an LLOQ of 10 ng/mL or whatever, and let us ignore the fact that the PAR above lists suitable time points. I want to investigate BE for a 160 mg IR SODF.
Who can write a function that uses some of the info in the links above (or other links deemed relevant) and makes a reasonable proposal?
Pass or fail!