PharmPK Discussion - Creams Bioequivalency

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On 12 Jan 2000 at 22:48:37, "Osama Ziada" (oziada.-at-.hotmail.com) sent the message


Happy new year to you

I would like to ask if Lignocain cream product need to have
bioequivalecy, as the effect depend on the level of local absorption ?
Thank you

Osama Ziada

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On 26 Jan 2000 at 00:01:40, "medical" (medical.aaa.wilnetonline.net) sent the message


I suppose if you checked up the US FDA site for this fda.org or nih.gov you
would get the answer.
Amit Taneja

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On 26 Jan 2000 at 23:55:02, AndyOConn.-a-.aol.com sent the message


I think the current thinking about creams and bioequivalency usually involves
demonstrating and equivalent effect as opposed to an equivalent amount of
drug absorption at the treatment site on the skin.  However, there was a
proposal by a  gentleman at the FDA to use dermal drug concentration
measurements, measured by tape stripping and analyzed using
"dermatopharmacokinetics" to establish bioequivalency.  There was document
available on the FDA website discussing this and paper in an AAPS publication
in 1997 that discussed this also.

Andy O'Connor

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