http://exhibits.library.stonybrook.edu/mfp/files/original/7be9d83de7f54d091c3e54f07170327b.pdf 80eaeba799ddc4e572424cd533a26c0e PDF Text Text April ll, 1986 Mr. A. J. Roccograndi Sonnenreich 6c Roccograndi P.C. Watergate 600 Suite 720 600 New Hampshire Avenue, N.W. Washington, D.C. 20037 Dear Mr. Roccograndi, Dr. Robert Millman sent me a 'copy of your letter of March 21 regarding the petition to the FDA on bioequivalence. i had written to Dr. Miliman of my interest in this topic and my concerns that the acceptance of bioequivalence for psychoactive substances on the basis of in vitro tests was inadequate since their penetration of the blood brain barrier was an important characteristic of their actions. My opinion is based on numerous studies of the CNS effects of psychoactive substances as reflected in quantitative EEG measures. 7 should like to encourage the petition to the FDA to review the requirements for demonstrating bioequivalence of psychoactive drugs. My experience was cited by the Hottmann La Roche petition to the FDA for a review of bioequivalency standards with specific regard to diazepam (Valium). The work was cited in support of the data developed by Professor [til of the New York Medical College. 1 enclose a copy of my letter to Bob Millman, as well as a recent report in which 1 reviewed my expereinces with this problem. You may, of course, cite the article if it seems helpful. 1 Good luck in your efforts. Sincerely yours, Max Fink, M.D. Professor of Psychiatry � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Correspondence Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Correspondence to: Roccograndi, Anthony J. Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-030-8-243 Date A point or period of time associated with an event in the lifecycle of the resource 1986 Creator An entity primarily responsible for making the resource <a title="Fink, Max, 1923-" href="http://id.loc.gov/authorities/names/n79039548" target="_blank">Fink, Max, 1923-</a> Subject The topic of the resource Correspondence -- Correspondence Relation A related resource The Max Fink Collection Description An account of the resource Rights Information about rights held in and over the resource <a title="IN COPYRIGHT - EDUCATIONAL USE PERMITTED" href="http://rightsstatements.org/vocab/InC-EDU/1.0/" target="_blank">IN COPYRIGHT - EDUCATIONAL USE PERMITTED</a> Source A related resource from which the described resource is derived Special Collections and University Archives, University Libraries. Stony Brook University Libraries (State University of New York). Language A language of the resource en-US Format The file format, physical medium, or dimensions of the resource application/pdf Publisher An entity responsible for making the resource available Contributor An entity responsible for making contributions to the resource Correspondence