Bioequivalence and Bioavailability Forum

Dear HS,

thank you for this interesting link.

I think I have a brilliant idea:
The human factor is a major cause of variation in virtually all processes we try to control. To give an example just think of pilot fatigue which has the potential to mean the difference between life or death for a lot of people.
Same goes for those who blend powders, integrate chromatograms, make stock solutions, take thoracic x-rays and much much more. Obviously, we need those people to perform optimally, or at least above a certain threshold. In other words they need to be within specs and we accordingly need to establish their design space. Therefore, I suggest we immediately start putting electrodes on the heads of all lab technicians. They will be dosed with diazepam, propofol, amphetamine, caffeine and various other uppers and downers, performance will be recorded and analysed against the brain waves and CNS-test batteries in order to define the individual technician's optimal design space.
Next we will implement a dosing scheme where the technicians,as long as they are at work, are infused with the appropriate mix of drugs so that the technicians, by way of their individual brain wave patterns and design space, maintain their appropriate level of attention, alertness, intellectual capacity and so forth. It will be absolutely grand!!
You may be wondering if this does not violate any rights of the technicians involved? To that I can only answer no. In the grand scheme of things we are trying to ensure safe and efficacious medicines for hundreds of thousands of patients and thus the rights of some hundred technicians should not obstruct our path towards that noble goal.

I am sure you agree.


































Am I the only person who thinks QbD has gone completely out of hand?