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RegisterBE study for Minoxidil [Design Issues]
Hi jag009,
in my opinion, FDA will not be likely to accept a PK-study.
21CFR320.23: "For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action."
in my opinion, FDA will not be likely to accept a PK-study.
21CFR320.23: "For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action."
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- BE study for Minoxidil jag009 2025-02-20 06:24
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA PSGs: Alternative approach Helmut 2025-02-20 10:44
- BE study for Minoxidil drgunasakaran1 2025-02-21 00:57
- BE study for Minoxidil jag009 2025-03-01 03:20
- BE study for MinoxidilElMaestro 2025-03-01 20:29
- BE study for Minoxidil jag009 2025-03-01 03:20
Ing. Helmut Schütz