just need to know the P-K by studying in 20-100 HEALTHY persons.
Why it works?
it's in HEALTHY persons bc just wanted to know if it works in humans and that bio-availability is good and not many side effects. It's easier to do it in healthy persons. Rather than tell a target sick patients that we're giving you these drugs to see how much of it really is avaialble to work in your body but not really to treat you. Who sick patients would want to do that? They will be more like, let me know when it works and I'll come back for phase 2.
Also, if pt has liver disease, you don't want to study on the patient, becauase you need a baseline to see how much to give to this patient.
Why it works?
it's in HEALTHY persons bc just wanted to know if it works in humans and that bio-availability is good and not many side effects. It's easier to do it in healthy persons. Rather than tell a target sick patients that we're giving you these drugs to see how much of it really is avaialble to work in your body but not really to treat you. Who sick patients would want to do that? They will be more like, let me know when it works and I'll come back for phase 2.
Also, if pt has liver disease, you don't want to study on the patient, becauase you need a baseline to see how much to give to this patient.
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