E-drug: TB Drug Suppliers with FDA approval (cont'd)
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The two key points of these articles in the Vol 3 No 11 supplement of
the Int J. TB & Lung Disease is that bioavailability testing for
rifampicin is absolutely necessary (not a new finding, Acocella
reported this years ago) and that this bioavailability testing can be
done with an abbreviated protocol.
For regulatory authorities requiring evidence of bioavailability of
rifampicin is necessary and it is reasonable to require the provision of
such data to the authorities by the manufacturers. The establishment
of a network of WHO approved reference centers which is already
occurring, to check these assays will complete the cycle of assuring
the quality of FDC preparations.
Richard Laing
Richard Laing M.B. Ch.B. M.Sc. M.D. Tel 1-617-414-1444
Associate Professor, Fax 1-617-638-4476
Department of International Health, E-mail richardl@bu.edu
Boston University School of Public Health,
715 Albany Street, T4W
Boston MA 02118 USA
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