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The present work introduces a possible new therapeutic insulin administration dosing approach for T2DM patients.
There is in fact an 'anti-evergreening' clause which explicitly provides no new exclusivity period would be granted for "a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength".
The clause Representative Eshoo refers to does appear on its face to exclude changes that result in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength from being eligible for a new 12-year exclusivity period.
There were also significant differences in administration, dosing of the GSIs, and finally the fact that Paris et al. analyzed smaller sized tumors than in the present study.
This may be due to the route of administration, dosing, frequency, and most importantly, timing.
Likely variables that might represent important clinical differences included type of implant (cemented versus noncemented), timing of antibiotic administration, route of antibiotic administration, dosing of antibiotics, and type/spectrum of antibiotic.
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In this experiment, the administration dose of BTX-A was determined by our preliminary study.
In all studies, a commercially available gadolinium-based contrast agent was used for breast MRI at regular clinical administration doses.
Mean FAZA administration dose (MBq/g) calculated for animals belonging to each treatment group over 7 imaging sessions.
Baclofen administration dose dependently, although not specifically, reduced alcohol-reinforced responding to an extent comparable to that of naloxone.
We obtained data on the use of DMTs (administration doses), spasticity treatment (different medicines, doses, and health care) and relapse management (treatments and doses).
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