i my name is jennifer occur in geneva
and i'm a coauthor of the manuscript entitled
expansion of guidance for the day eight initiation does a power paradigm comedy
to avoid a mysterious
although symptoms of schizophrenia can be treated affectively with and i psychotic medication
for any hearing stupor scrap treatment is a well recognized problem
continuous and a psychotic their be is essential for achieving sistine symptom control
and for reducing the risk of relax and we hospitalisation
long acting intractable in a sec a text
provide a sustained release profile resulting in their pewter concentrations over several weeks
as a weapon eating the need for daily dosing
how dare don't comedy is a once monthly long acting intractable formulation of how paragon
approved in several countries for the treatment of schizophrenia in adults
after intra muscular administration of two initiation does is given one week apart in the
results right muscle
how appeared on comedy is administered monthly
and the child joint or video must so
the recommended initiation regimen is two hundred thirty four milligrams and a one
corresponding to a hundred and fifty milligrams of power paragon
followed by one hundred and fifty six milligrams and eight
corresponding to one hundred milligrams a power paradigm
previously of the powder don't comedy label indicated that the date eight injection could be
administered within plus or minus two days of date eight to avoid in ms jokes
without a clinically significant impact on how a parrot on plasma concentrations
them i don't we results presented here provide support for a more flexible initiation schedule
but they plus or minus board a dosing window for administration of the second dose
that is
the second injection can occur between day four and a twelve
to avoid in missed day eight injection
this is been approved by the food and drug administration
and the how appeared on comedy label
has been updated accordingly
in our article we report results of the analysis that form the basis for this
label update
the analysis included model based simulations
used to evaluate the potential the fax
of the day eight missed reducing window expansion
on power paradigm has not exposures
and potential implications for the safety and efficacy profile
no additional clinical trials were conducted which highlights the usefulness of model based approaches
and historical population five go kinetic model
was used to check whether it could appropriately predict exposures from various initiation regiments
here we can see that simulated profiles obtained using the model we're similar to those
obtained into pell appeared on comedy clinical studies
therefore the historical model is a suitable tool
for predicting exposures with other initiation regiments
if we hear on the left shows the comparison of model based approach actions
person is observed data with power paired on comedy one hundred and fifty milligram equivalence
on day one
followed by one hundred milligram equivalence and eight
the peak here on the right
shows a comparison with the dose of one hundred and fifty milligram equivalent on both
days one in and eight
in this figure from left to right
we see dosing a one hundred and fifty milligram equivalent and a one followed by
one hundred milligram equivalents on days for
eight and twelve
compared with the same with the maximum initiation regimen of one hundred and fifty milligram
equivalents i'm days one and eight
and one iteration of the second initiation does on day for eight or twelve
produced plasma exposures
not exceeding the exposure observed with the maximum initiation regiment
this maximum initiation regimen has previously been found to be generally well tolerated
with the cp profile similar to those of one hundred fifty milligram equivalence
until one and one hundred milligrams equivalence and eight
in conclusion our data from model based simulations suggest that an expansion at that a
eight ms toast window for power parent on how much say
two plus or minus four days appears to have minimal a fax
i'm class not how apparent concentrations
it would not pose efficacy or safety concerns during the initiation phase
impatience for home use of the expanded window is necessary to avoid a missed dose
we hope that this wider miss dosing window will support more practical clinical initiation of
power paired on comedy in the hospital setting particularly and those situations where the duration
of hospital stay will be short
thank you for your interest