Bioequivalence and Bioavailability Forum • multiple-dosed study with bear

multiple-dosed study with bear [🇷 for BE/BA]

posted by VStus – Poland, 2016-10-11 12:37 (3542 d 00:33 ago) – Posting: # 16720
Views: 16,284

Dear Yung-jin Lee,

❝ Please make sure that your T_last is set correctly (the dosing interval looks fine). For example, the following case has T_last = 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

Complete thread:

Difficulties with NCA BEAR PK_Lover 2014-11-21 00:28
- Difficulties with NCA BEAR yjlee168 2014-11-21 07:34
  - Difficulties with NCA BEAR PK_Lover 2014-11-22 00:07
    - Difficulties with NCA BEAR yjlee168 2014-11-22 03:21
      - Difficulties with NCA BEAR PK_Lover 2014-11-22 09:47
        
        help test NCA BEAR yjlee168 2014-12-01 08:13
        
        help test NCA BEAR Emrah Soner Özdeş 2015-01-15 14:37
        
        help test NCA BEAR Jam 2015-01-23 08:55
        
        CSV files with a comma at the end of each line? yjlee168 2015-01-25 04:35
      - Difficulties with NCA BEAR xtianbadillo 2016-09-15 22:44
        
        old bear and friends yjlee168 2016-09-16 09:42
        
        old bear and friends VStus 2016-09-26 13:30
        
        multiple-dosed study with bear yjlee168 2016-09-26 18:04
        
        multiple-dosed study with bear VStus 2016-10-11 09:01
        
        multiple-dosed study with bear yjlee168 2016-10-11 10:15
        
        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