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                  <text>February 25, 1986
Mr. Steve Moore
FDA Center for Drugs and Biologics (HFn—ZSO)
5600 Fishers Lane
Rockville, Maryland 20857
‘

Dear Mr. Moore,
1 became aware of the FDA Bioequivalence
Workshop to consider the
in vivo testing of pharmaceuticals on May 7-9, in reading the PMA
of
design
Newsletter of February, 1986 (page 6). i have been testing psychotropics for their
effects, on brain function using quantitative EEG measures for many years, and
have carried out a numbq of bioequivalency studies. Lately, i was asked by the
physicians at Hottmann La Roche Laboratories to consult on the issues of
bioequivalence of generic formulations of diazepam with Valium. it is my
understanding that these data led to a request by Hoffmann La Roche to the FDA
to consider quantitative pheromone-EEG measures in the development of guidelines
for bioequivalency of psychotropic drugs.
’

Will these questions be part of the discussion and presentation
meetings? Would your ofﬁce send me a copy of the program?

Many thanks.

Sincerely yours,
Max Fink, M.D.

Professor of Psychiatry

at the

May

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              <text>Special Collections and University Archives, University Libraries. Stony Brook University Libraries (State University of New York).</text>
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