Sachet thoughts: If we look at the 3 states of
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Posted On: 12/02/2018 4:15:36 PM
Sachet thoughts:
If we look at the 3 states of matter, the P2 trial was done with the liquid state of Brilacidin with further trials and commercial product being in the solid state of the drug. I view the powder to be used in the sachet as the same chemical Brilacidin as P2 with some inert additives to convert it to a solid state.
Does this change in state require new testing of the sachet product? I would say no if the additives are truly inert as the Brilacidin will be the same strength in the sachet as found in the P2 liquid medication.
If the FDA deems it does require testing, would that need to be a separate clinical trial or could IPIX hire a CRO or hospital to test the sachet on healthy people and take the necessary blood tests to check on the physiokinetic properties of the sachet product? If this is true, could IPIX possibly have done this already so that the P3 or P3/P4 could begin planning immediately?
Would appreciate responses from those familiar with this type of situation.
If we look at the 3 states of matter, the P2 trial was done with the liquid state of Brilacidin with further trials and commercial product being in the solid state of the drug. I view the powder to be used in the sachet as the same chemical Brilacidin as P2 with some inert additives to convert it to a solid state.
Does this change in state require new testing of the sachet product? I would say no if the additives are truly inert as the Brilacidin will be the same strength in the sachet as found in the P2 liquid medication.
If the FDA deems it does require testing, would that need to be a separate clinical trial or could IPIX hire a CRO or hospital to test the sachet on healthy people and take the necessary blood tests to check on the physiokinetic properties of the sachet product? If this is true, could IPIX possibly have done this already so that the P3 or P3/P4 could begin planning immediately?
Would appreciate responses from those familiar with this type of situation.
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