vol1 - Page 246



Page 246 Previous , Next , Original Image
Return to Index

 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




Previous , Next , Return to Index