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Avastin had been approved based on a trial that showed it delayed the worsening of tumors by 5.5 months — almost as big a gain as seen now with pertuzumab.
New intravenous (iv) TMZ formulations have recently been approved based on studies of bioequivalence between iv and oral TMZ.
Many flavouring agents have been approved based on long history of safe use (i.e. grandfathered) or through use of the TTC approach.
We know of no interventions for the control of bleeding or fluid resuscitation that have been approved based on a reduction in mortality in trauma patients.
There are only a few available options for the treatment of purulent bacterial conjunctivitis with topical antibiotics in children 11 as most available topical antibiotics have been approved based on clinical studies performed only in adults.
Most currently licensed topical antibiotics for bacterial conjunctivitis have been approved based on clinical studies conducted mainly in adults 11, with insufficient clinical data in newborns and infants (ie, <24 months).
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The ophthalmic drugs in our study cohort were approved based on a median of two pivotal trials, compared with a median of one pivotal trial per device approval.
For example, an insulin biosimilar could be approved based on a study in people with type 1 diabetes, but upon approval, it would receive approval for use in all patient populations for which the reference product has been approved (e.g., type 2 diabetes, pediatrics).
Projects are approved based on the amount of energy saved and their cost.
The modeling is approved based on a large number of tests on 304 stainless steel and is compared with SWT and FS models.
Keytruda was approved based on what was essentially an extra-large Phase 1 trial involving 173 participants who all received the drug, with no control group.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com