Menschliche Besonderheiten, Empfindlichkeiten, Idiosynkrasien, Fähigkeiten, "Abweichen von der Norm"
@lymphomation The missing word (and principle) throughout is #individualization, which makes all the difference. This distinction between dose individualization & the 'optimization' of a one-size-fits-all dose proved impossible for FDA to face, once it was articulated clearly.
Reviewer 2 of above PSP paper was FDA OCE, and all they did was flail desperately. Not a pretty sight for someone enamored of gubmint regulation!






