vol1 - Page 246
Page 246
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Fortunately, one drug, timolol, approved a decade ago
for the indication of IOP reduction in the treatment of
glaucoma, provides a benchmark against which we can more properly
w
evaluate marijuana. According to Keith Green, Ph.D.: IF]or
Timolol weSre using almost present day standards in terms of
_D
getting it onto the marketo _ He calls timololts testing
#rigorousWo_//
During redirect Ms. Shirley asks Green several
questions with regard to timo!olSs evaluation by FDA under the
IND/NDA drug marketing procedures. She asks, Wapproximately how
many patients were studied throughout the course of preparing
[timolol] for marketing? u Green responds, #I don;t know the
number specifically_ . . . the nnmhers are like three or 400
i patients_'54_/
..... In cross-examinin_ Dr. Merritt, Ms. Shirley asserts:
Shirley: Now_ I believe you claimed and
Doctor Green also claimed, that somewhere
between 300 and 400 patients were treated
with Timolol through chronic administration
during the testings is that correct?
Merritt: I didn;t claim that_ Maybe Doctor
Green did. I don_t know if that's true or
not .... In the single-dose [acute]
studies that may have been the case. I don;t
know if they were all long term_ but I dontt
think it was that many_ nearly that many
[research subjects]°
Shirley: But, there were long-term tests
done with the drug.
542/ Id. at 9-78.
...... _i/ /A. at 9-157o
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