“This explains that two simple seizure models in mice and rats, the MES and s.c. pentylenetetrazole (PTZ) tests, which have been developed >60 years ago, are still the most widely used animal seizure models employed in the search for new AEDs. ... Anticonvulsant spectrum of AEDs in models and man. “NE” = not effective.”
I therefore believe (reminder I’m not an expert so check my work) that what you are looking at is the “mouse dose” and would need to use the conversion formula ...
HED (mg/kg) = Animal Dose (mg/kg) x [Animal Km / Human Km]
Human Km = 37
Mouse Km = 3
Rat Km = 6
EXAMPLE:
Say a STUDY conducted on MICE reports that a dosage of 5mg/kg was used; what is the HED?
By calculation, the HUMAN EQUIVALENT DOSE (HED) = 5 x [3 / 37] = 0.405 mg/kg
To get the equivalent human dose. If, if, if that is correct and we used a weight of 20 kg for the typical Rett patient, what would the HED be?
Good and so some are presuming 30mg scaled down to little girls is not tolerable, on what basis?
I think you have the logic backwards there. The FDA will demand a data driven clinical trial protocol. They will incorporate the only HUMAN data they have for tolerability before giving 2-73 to HUMAN children. That HUMAN data suggests that the majority of adults with an average weight of ~76.5kg do not tolerate doses above 30mg.
If you do the conversion that F1ash gave you for mouse data you'll see that a 5mg/kg MOUSE dose converts to 31mg in a 76.5kg HUMAN. I think in a different post you used 100mg instead of the 100mg/kg used in the seizure study. I've been pointing out for a very long time the high doses needed for effect. Maybe now it's more apparent.
BTW, since the relationship is linear you can multiply from 5mg/kg equivalent 76.5kg human dose of 31mg as needed. So 10mg/kg is 62mg and 100mg/kg is 620mg. You can go back to pediatric dosing from there.
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