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My questions are relative to in vivo tox models of monoclonal
antibodies that are intended for therapy of human solid tumors.
How important, for the planning of an in vivo tox study of a
monoclonal antibody in a large animal (e.g. non-human primate), is it
to understand how the tumor burden affects the PK of the antibody in
a PK/PD study (in an in vivo efficacy model of that antibody) and how
is the data analyzed, i.e. what types of models should be used to
analyze the data obtained in these conditions? And what are the
guidelines for scaling up the dosages to be tested on the in vivo tox
model from those found effective in the in vivo efficacy model of
I truly appreciate any information or suggestions on this area.
Best regards to all,
Luis da Cruz
Arius Research Inc.
55 York Street, 16th floor
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