vol2 - Page 333

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 eye pressure?
 E And maintenance of visual field. I mean
 3 the initial test that one _- you have to put this
 4 into perspective° _ mean mo_t of these drugs have
 5 been around long enough that the newer criteria we
 - - 6
 - - have become aware of as the s_ience or the practice
 7- of ophthalmology or any other discipline has
 developed have led to the establishment of different
 9 criteria as time has gone by_ So we are much more
 10 cognizant of the fact that we need to look at
 11 different things.
 12 So Sf_ says we cam_ up with Green's new
 ...... 13 wonder d_g_ then we would hav_ to go through several
 14 steps to comply with the law, ._nd alsoo several steps
 15 to prov_ to the optometric co_nunlty that that drug
 _6 was efficacious.
 17 Now_ in the first phase, one would simply
 18 show that the drug didn't have people die on you and
 1% it didn't cause overt toxicity .when it was =-
 20 q_ So safety?
 2i _ Safety, that's the first, phase one of any
 22 FDA study _
 23 Phase two, you look at various doses and
 24 then try and pick a good one that will optimally do
 one of the primary things that you want to do. Zn
 N_AL Ro GRO55
 '_23 RHODE _$LAND AV_:U_. N.W. !
 (202) 234._ WASHINGTON. DoC0 _˘_05 (202_ 232-8600
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