Dear all,
is anybody aware of statistically oriented articles about SAD and MAD
studies as they are done in early drug development. I would be
interested in (more statistically oriented) articles or books dealing
with any aspect or issues that arise during the planning or conduct
phase of such studies. An internet search just led to case studies,
which is not what I was looking for. My interest is in methodology, whey
are they done the way we do them, what alternative designs are there,
how many pts are really needed etc.
Many thanks in advance for your help.
Kind regards
Markus
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