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RegisterAUC72 [Design Issues]
Hi Helmut,
You do look like the guy in the picture --> Highlander
Well I did some literature research this morning and found an article which studied the pk of a combination product that contained my drug of interest. It was a simple one arm study (one product, single dose exposure). Based on the mean AUC and SD, I think the inter CV is around 30% (I know I know, this is rough and dirty..)
Regarding truncate AUC (72 hours), yes that would help and it is an IR formulation. But I am still looking for a month for washout + 3 days...
The half-life of 100-120 hr is the reported mean but there have been values of 150 hr reported as well. I still need to find out what the lab will have as the LLoQ..
Regarding LLoQ, is there any requirement as to how low you have to go? I mean if I am aiming for less than 5% of the theoretical Cmax, would that do?
Claymore? I always wanted a samurai sword myself
John
You do look like the guy in the picture --> Highlander
Well I did some literature research this morning and found an article which studied the pk of a combination product that contained my drug of interest. It was a simple one arm study (one product, single dose exposure). Based on the mean AUC and SD, I think the inter CV is around 30% (I know I know, this is rough and dirty..)
Regarding truncate AUC (72 hours), yes that would help and it is an IR formulation. But I am still looking for a month for washout + 3 days...
The half-life of 100-120 hr is the reported mean but there have been values of 150 hr reported as well. I still need to find out what the lab will have as the LLoQ..
Regarding LLoQ, is there any requirement as to how low you have to go? I mean if I am aiming for less than 5% of the theoretical Cmax, would that do?
Claymore? I always wanted a samurai sword myself
John
Complete thread:
- Parallel study as pilot for long half life drug jag009 2012-05-07 15:13 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Parallel study as pilot for long half life drug Dr_Dan 2012-05-07 16:00
- Parallel study as pilot for long half life drug d_labes 2012-05-07 16:24
- Parallel study as pilot for long half life drug jag009 2012-05-07 18:15
- AUC72 Helmut 2012-05-07 19:31
- AUC72jag009 2012-05-07 20:15
- AUC72 Dr_Dan 2012-05-08 12:17
- AUC72 jag009 2012-05-10 15:15
- AUC72: NDAs Helmut 2012-05-10 15:56
- AUC72: NDAs jag009 2012-05-14 15:22
- AUC72: NDAs Helmut 2012-05-10 15:56
- AUC72 jag009 2012-05-10 15:15
- AUC72 Dr_Dan 2012-05-08 12:17
- AUC72jag009 2012-05-07 20:15
- AUC72 Helmut 2012-05-07 19:31
- Parallel study as pilot for long half life drug Dr_Dan 2012-05-07 16:00
Ing. Helmut Schütz