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The following message was posted to: PharmPK
I would like to know considerations for determining BE for an anally
applied
topical drug product that is intended for local action (no doubt
absorption
occurs and the absorbed product - a corticosteroid/local anesthetic or
single agent corticosteroid - could have some systemic activity, but
again,
the treatment site is local and is not intended for rectal
administration).
This would be for ANDA purposes.
Peter
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)