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RegisterHow to confirm a drug is a highly variable drug? [Design Issues]
Hi wxp,
For EU and US submissions the safe route is not just literature. If you conduct a study and conduct it well and with an appropriate design, and the intra-CV is >30% then you have reached the goal. Some member or other may chime in with the distinction between drug and drug product.
❝ I wonder how to confirm a highly variable drug?
For EU and US submissions the safe route is not just literature. If you conduct a study and conduct it well and with an appropriate design, and the intra-CV is >30% then you have reached the goal. Some member or other may chime in with the distinction between drug and drug product.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- How to confirm a drug is a highly variable drug? wxp 2013-03-21 15:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- How to confirm a drug is a highly variable drug?ElMaestro 2013-03-21 16:07
- How to confirm a drug is a highly variable drug? wxp 2013-03-22 01:58
- How to confirm a drug is a highly variable drug? ElMaestro 2013-03-22 10:33
- Confirm a reference drug is highly variable d_labes 2013-03-23 15:37
- Confirm a reference drug is highly variable wxp 2013-03-25 14:24
- Confirm a reference drug is highly variable d_labes 2013-03-23 15:37
- How to confirm a drug is a highly variable drug? ElMaestro 2013-03-22 10:33
- HVD ≠ HVDP Helmut 2013-03-23 17:35
- HVD ≠ HVDP wxp 2013-03-25 14:20
- How to confirm a drug is a highly variable drug? wxp 2013-03-22 01:58
- How to confirm a drug is a highly variable drug?ElMaestro 2013-03-21 16:07
Ing. Helmut Schütz