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RegisterBE study for Minoxidil [Design Issues]
Hi,
As per FDA guidance the in-vivo BE route for Minoxidil 5% topical requires a clinical endpoint study because the drug cannot be quantified in plasma due to its low system bioavailability (1.4%) when administered topically. Since this guidance was written in 2011, is it possible to suggest a PK BE study now since we have systems that are capable of measure drugs at very low concentrations?
Minoxidil Topical
Thx
J
Edit: Category changed. [Helmut]
As per FDA guidance the in-vivo BE route for Minoxidil 5% topical requires a clinical endpoint study because the drug cannot be quantified in plasma due to its low system bioavailability (1.4%) when administered topically. Since this guidance was written in 2011, is it possible to suggest a PK BE study now since we have systems that are capable of measure drugs at very low concentrations?
Minoxidil Topical
Thx
J
Edit: Category changed. [Helmut]
Complete thread:
- BE study for Minoxidiljag009 2025-02-20 06:24 [Design Issues]
![[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 Minoxidil ElMaestro 2025-03-01 20:29
- BE study for Minoxidil jag009 2025-03-01 03:20
Ing. Helmut Schütz