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Dear members,
i need to know about the bioequivalence procedure for topical
preparation.i could not get any guidelines for this.
can you help me in getting it.
with thanks,
M.francis
research scientist
quest life sciences
chennai
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Dear M. Francis,
Currently there is no guidance on topical bioequivalence from FDA.
Skin blanching assay was used for topical steroids and tape stripping
(now obsolete) was another option. Currently cutaneous microdialysis
is a promising option but no official guidacne is issued. Efficacy
measures are the only way to prove equivalence if no blood levels are
detected but are very expensive studies! I would appreciate more
insight into this issue.
Thanks
Ayyappa Chaturvedula
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