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I would like to know the opinion of yours about the necessity of
doing a new bioequivalence study, for modified release solid forms,
when the site, only the site, is changed.
Regards,
Kelen
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Dear Kelen
As per USFDA guideline, Guidance for Industry SUPAC-MR: Modified
Release Solid Oral Dosage Forms (http://www.fda.gov/cder/guidance/
1214fnl.pdf ) if the site of manufacturing is changed to a different
geographic location (different campus) a single dose bioequivalence
study is required. But this criteria may be waived in presence of an
established in-vitro/in-vivo correlation data.
Hope this helps.
Regards
Aparna Parinam
ratiopharm
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