| 0:00:00 | i my name is jennifer occur in geneva |
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| 0:00:03 | and i'm a coauthor of the manuscript entitled |
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| 0:00:06 | expansion of guidance for the day eight initiation does a power paradigm comedy |
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| 0:00:11 | to avoid a mysterious |
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| 0:00:14 | although symptoms of schizophrenia can be treated affectively with and i psychotic medication |
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| 0:00:20 | for any hearing stupor scrap treatment is a well recognized problem |
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| 0:00:24 | continuous and a psychotic their be is essential for achieving sistine symptom control |
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| 0:00:31 | and for reducing the risk of relax and we hospitalisation |
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| 0:00:35 | long acting intractable in a sec a text |
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| 0:00:37 | provide a sustained release profile resulting in their pewter concentrations over several weeks |
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| 0:00:44 | as a weapon eating the need for daily dosing |
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| 0:00:47 | how dare don't comedy is a once monthly long acting intractable formulation of how paragon |
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| 0:00:54 | approved in several countries for the treatment of schizophrenia in adults |
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| 0:00:59 | after intra muscular administration of two initiation does is given one week apart in the |
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| 0:01:05 | results right muscle |
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| 0:01:06 | how appeared on comedy is administered monthly |
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| 0:01:09 | and the child joint or video must so |
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| 0:01:12 | the recommended initiation regimen is two hundred thirty four milligrams and a one |
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| 0:01:18 | corresponding to a hundred and fifty milligrams of power paragon |
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| 0:01:22 | followed by one hundred and fifty six milligrams and eight |
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| 0:01:26 | corresponding to one hundred milligrams a power paradigm |
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| 0:01:30 | previously of the powder don't comedy label indicated that the date eight injection could be |
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| 0:01:36 | administered within plus or minus two days of date eight to avoid in ms jokes |
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| 0:01:42 | without a clinically significant impact on how a parrot on plasma concentrations |
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| 0:01:47 | them i don't we results presented here provide support for a more flexible initiation schedule |
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| 0:01:54 | but they plus or minus board a dosing window for administration of the second dose |
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| 0:02:00 | that is |
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| 0:02:01 | the second injection can occur between day four and a twelve |
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| 0:02:06 | to avoid in missed day eight injection |
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| 0:02:09 | this is been approved by the food and drug administration |
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| 0:02:13 | and the how appeared on comedy label |
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| 0:02:15 | has been updated accordingly |
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| 0:02:18 | in our article we report results of the analysis that form the basis for this |
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| 0:02:23 | label update |
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| 0:02:25 | the analysis included model based simulations |
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| 0:02:29 | used to evaluate the potential the fax |
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| 0:02:31 | of the day eight missed reducing window expansion |
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| 0:02:35 | on power paradigm has not exposures |
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| 0:02:38 | and potential implications for the safety and efficacy profile |
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| 0:02:43 | no additional clinical trials were conducted which highlights the usefulness of model based approaches |
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| 0:02:49 | and historical population five go kinetic model |
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| 0:02:53 | was used to check whether it could appropriately predict exposures from various initiation regiments |
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| 0:03:00 | here we can see that simulated profiles obtained using the model we're similar to those |
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| 0:03:06 | obtained into pell appeared on comedy clinical studies |
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| 0:03:10 | therefore the historical model is a suitable tool |
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| 0:03:14 | for predicting exposures with other initiation regiments |
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| 0:03:19 | if we hear on the left shows the comparison of model based approach actions |
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| 0:03:23 | person is observed data with power paired on comedy one hundred and fifty milligram equivalence |
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| 0:03:29 | on day one |
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| 0:03:30 | followed by one hundred milligram equivalence and eight |
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| 0:03:34 | the peak here on the right |
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| 0:03:36 | shows a comparison with the dose of one hundred and fifty milligram equivalent on both |
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| 0:03:40 | days one in and eight |
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| 0:03:45 | in this figure from left to right |
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| 0:03:47 | we see dosing a one hundred and fifty milligram equivalent and a one followed by |
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| 0:03:52 | one hundred milligram equivalents on days for |
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| 0:03:55 | eight and twelve |
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| 0:03:56 | compared with the same with the maximum initiation regimen of one hundred and fifty milligram |
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| 0:04:01 | equivalents i'm days one and eight |
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| 0:04:05 | and one iteration of the second initiation does on day for eight or twelve |
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| 0:04:10 | produced plasma exposures |
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| 0:04:12 | not exceeding the exposure observed with the maximum initiation regiment |
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| 0:04:18 | this maximum initiation regimen has previously been found to be generally well tolerated |
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| 0:04:24 | with the cp profile similar to those of one hundred fifty milligram equivalence |
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| 0:04:29 | until one and one hundred milligrams equivalence and eight |
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| 0:04:34 | in conclusion our data from model based simulations suggest that an expansion at that a |
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| 0:04:41 | eight ms toast window for power parent on how much say |
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| 0:04:44 | two plus or minus four days appears to have minimal a fax |
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| 0:04:49 | i'm class not how apparent concentrations |
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| 0:04:52 | it would not pose efficacy or safety concerns during the initiation phase |
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| 0:04:57 | impatience for home use of the expanded window is necessary to avoid a missed dose |
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| 0:05:04 | we hope that this wider miss dosing window will support more practical clinical initiation of |
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| 0:05:09 | power paired on comedy in the hospital setting particularly and those situations where the duration |
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| 0:05:15 | of hospital stay will be short |
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| 0:05:17 | thank you for your interest |
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