Drug Bioequivalence Page: 73
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73
each group. These groups were also asked to submit
additional documentation by May 20.
Since many professional and scientific organizations,
government agencies, manufacturers and academic
institutions were willing and anxious to present
information and to provide assistance, the April
23 news release was used as a public announcement
inviting interested groups and individuals to
submit statements for consideration. It was made
clear that their submissions would be given full
consideration although time constraints made their
direct testimony impossible. Many statements
containing information related to the issues of
the study were received, including letters from
individuals and organizations and reports from
pharmaceutical manufacturers.
After the May 1-2 meeting, the staff was directed
to continue its collection of relevant data.
Information from two programs in Canada--the
PARCOST Program in Ontario and the Federal QUAD
Program in the Health Protection Branch, Canadian
Department of National Health and Welfare--was of
particular interest since the experiences of these
two programs were especially relevant to the issues
under examination.
In preparation for the third panel meeting on May
21-22, members accepted individual assignments to
review and report on the data that had been
submitted. Most documentation, however, was
submitted on or close to the May 20 deadline,
leaving little time for review before the third
meeting of the Panel. On May 21, published studies
of bioequivalence and the additional documentation
that had been received were reviewed and summarized.
Using this information and discussions based upon
it as well as the knowledge and experience of its
members, the Panel proceeded to formulate a series
of conclusions and recommendations about present
and future technological capability for assuring
uniform bioavailability and quality of drug products.
By the conclusion of the third meeting, a tentative
set of conclusions and recommendations had been
agreed upon. Members of the group were assigned
the task of writing supporting information and
providing data that would go into the final report
to be submitted to OTA.
The written recommendations were submitted to the
Chairman for review prior to the final meeting on
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United States. Congress. Office of Technology Assessment. Drug Bioequivalence Study Panel. Drug Bioequivalence, report, July 1974; [Washington D.C.]. (https://digital.library.unt.edu/ark:/67531/metadc39335/m1/73/: accessed April 24, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.