Pharmacology question

1) Utilize the following case study to evaluate and communicate your thinking on
developing a compliant life-cycle management strategy:
Imagine that you, as a regulatory science expert, go camping in a
remote area of the world, and find an isolated tribe of people that has
not yet communicated with the rest of the world. You discover that this
tribe uses several types of “magic dust” to treat a wide variety of human
ailments, each with varying safety profiles and degrees of efficacy. For
example, the tribe uses “magic dust #1” to treat headaches, nausea,
fever and mild systemic pain, “magic dust #2” to treat cuts and bruises,
and “magic dust #3” to treat insect bites. In fact, you observe that the
tribe has isolated or developed at least 12 different kinds of “magic
dust” and your observations suggest that the “magic dust” category as
a whole seems to have a novel mechanism of action. You ask the tribe if
you can have samples of each magic dust type to bring back home with
you for analysis and they agree. When you get home, you give these
samples to the medical research community, which discovers that
indeed, these “magic dusts” might possibly be used effectively in the US
to treat the conditions for which they are utilized by the tribe, and that
their pharmacodynamic mechanism of action is, indeed, unique.



Powered by WordPress