multiple-dosed study with bear [🇷 for BE/BA]
Dear Yung-jin Lee,
My dataset includes only concentrations obtained during last (7th) day of treatment period. Last tablet was given on 7th day (that's why I've entered 168 hrs). Sampling is 24 hrs (for dosing period-only). Change of Tlast to 120 not helps.
My understanding is that I should add pre-steady state samples. Correct?
I've removed it intentionally from post to avoid breaking NDA :)
Regards, VStus
❝ Please make sure that your Tlast is set correctly (the dosing interval looks fine). For example, the following case has Tlast = 120 and dosing interval = 24.
My dataset includes only concentrations obtained during last (7th) day of treatment period. Last tablet was given on 7th day (that's why I've entered 168 hrs). Sampling is 24 hrs (for dosing period-only). Change of Tlast to 120 not helps.
My understanding is that I should add pre-steady state samples. Correct?
❝ BTW, in your setting why dose (mg)? dose
?
I've removed it intentionally from post to avoid breaking NDA :)
Regards, VStus
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- multiple-dosed study with bearVStus 2016-10-11 10:37
- multiple-dosed study with bear VStus 2016-10-12 10:37
- multiple-dosed study with bear [solved] yjlee168 2016-10-12 18:42
- multiple-dosed study with bear yjlee168 2016-10-11 10:15
- multiple-dosed study with bear VStus 2016-10-11 09:01
- multiple-dosed study with bear yjlee168 2016-09-26 18:04
- old bear and friends VStus 2016-09-26 13:30
- old bear and friends yjlee168 2016-09-16 09:42
- Difficulties with NCA BEAR PK_Lover 2014-11-22 09:47
- Difficulties with NCA BEAR yjlee168 2014-11-22 03:21
- Difficulties with NCA BEAR PK_Lover 2014-11-22 00:07
- Difficulties with NCA BEAR yjlee168 2014-11-21 07:34