http://exhibits.library.stonybrook.edu/mfp/files/original/e7cfd9233cbaec8c05748752620f96cb.pdf 3a4c8fe17eba6f05dd508cd0f5342d11 PDF Text Text .u'rvn awe—wk February 2, 1971 Dr. Marion J. Finkel Deputy Director Bureau of Drugs war-3w:- Food and Drug Administration Rockville, Maryland 20852 Dear Dr. Finkel: letter of January 25, is encouraging. As a of new drugs with industrial support participant in the evaluation and in attempting studies of drugs of limited commercial interest (notably the narcotic antagonists cyclazocine and naloxone), I would support your suggested use of seminars. There may provide the opportunity for researchers and administrators to reconcile differences in their opinions on the requirements for studies in Your thoughtful man. I would be willing to participate as a speaker or panellist. "criteria” of animal toxicology which must be satisfied before drugs are taken to man is an issue that has provided much travail in studying new drugs. Specifically, I have been repeatedly The ....-.—.. V agar”... «twim-wwuw,‘ P‘N1"-V"r\"';m.‘-utn ~:-z row“: w n-w- rr'vwmmwww -:- advised that certain trials in man were not ”proper” or "legal” without extensive animal trials in 2 (or 3) species for 3 (or 6 or 12) months with_a variety of pathological studies. An irony of these "recommendations” (or ”guidelines”) is he experience that teratogenicity and toxicity are determined as much by differences among species and among individuals as by dose, duration, and route of compound administration. A slavish recourse to a presumed minimum animal toxicology profile has made much research too expensive, especially where compounds do not have an immediate potential for financial success. issue that haa’been of personal interest is the improvement of methods for the assay of psychoactive drugs in volunteers by the use of physiologic indicea, particularly measures of the CNS like the quantitative EEG. But this issue may be too technical for general discussion. An �r —-r'-r'-JWV u w M my» :.-:>-n ,w—m rw‘w - 2m“; Viv-FIL-g'w‘«:12» ‘r: nus-us, ,z-l.‘ ww- rwav .14' . "'r-w- wmv- :w. ‘4’WWHk’KEr‘flv-F7Ar'fi ‘J'ou-T—r': ,- - ~. ,. ~ch ..--v_ if Dr. Finkel -‘ v.~'—\1\'W»’zavrme'W'OI-‘W'fw‘w 1—7~'1€.\$‘ -2- February 2, 1971 Such meetings should be encouraged, to allow additional intercourse between administrators and reeearchers, to allay the suspicions that have arisen aince the guidelines were first proposed. Thank you for your invitation, and I do believe that such public seminars will be papular and well subscribed, reflecting an important concern of researchers, industry and government. Sincerely yours, Max Fink, M.D. Professor of Psychiatry Mszt .7 . u ,~,‘.,,,.,rM—,- . .— . zuv‘w-wuuv-w-wr: 7,. 1- _ H . .7, — “M. 1— .. 1..» , � 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: Finkel, Marion Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-025-2-160 Date A point or period of time associated with an event in the lifecycle of the resource 1971 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