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Post by hotelcalifornia on Jan 3, 2014 14:05:56 GMT -5
How much more difficult is it to get into a safety study, especially First in Man, vs. a biological, pharmacokinetic study?
I am just now realizing that all the past studies I've gotten into no problem were all bio studies (by chance), but the last two I've tried I've barely missed because of an EKG number that was .002 out of range.
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Post by vark on Jan 3, 2014 16:38:56 GMT -5
some labs are stricter about ekg's for first inhuman studies. i don't have numbers, that's just been my experience.
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Post by hotelcalifornia on Jan 3, 2014 18:36:58 GMT -5
Thx. Just going for non-safety studies from here on out. In this numbers game, it seems to be much less worthwhile time-wise and if you do enough FIM safety studies you raise your overall risk in the long run; there's also the opportunity cost of a missed study you could have gotten into. I guess I'm not 22 anymore, and i do not do this for a living at all, but recently did the NASA study (short term) and if my ekg was ever fine in all respects, it was for that. Just burns to miss by a hair, knowing that I am fit in all other respects. Makes sense though, to have subjects with numbers that split the median of the range (or at least not bumping the ends) for comfort of movement up and down after dosing in terms of overall safety, especially if your main window into changes is the EKG. I have respect for and defer to the decisions of the medical staff either way. It's about the study and the safety of the drug and not me. Just frustrating.
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