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Can anyone give me examples of a dosing regimen that has been approved by the
regulatory agency based on M&S? We are proposing testing a dose 'X' in a Phase 3
trial but do not have any PK samples planned. I am trying to convince the team
to collect plasma samples for PK in patients so that if the dose X is found to
be inadequate, we could propose dosing patients with a dose of 2X without doing
a Phase 3 study in patients i.e. show that exposure-response is likely to be
better at 2X.
The counter argument to this is that agencies will not approve the 2X dose
unless it has been studied in patients in a Phase 3 trial. I seem to remember
from a webinar (perhaps by Joga?) that indicated the possibility of using M&S to
justify using a higher dose. An example to that effect will be very helpful.
Other related information: the safety of 2X dose has been established in healthy
volunteers and it has been shown to be safe (N=12). The class to which this drug
belongs is also known to be generally safe and well-tolerated.
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I have a rather dim recollection that the first time FDA proposed dosing based
just on PK rather than empirical clinical trial data was at the time Carl Peck
was CDER director. I think FDA proposed a loading dose for ketorolac using a
dose that had never been studied.
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