Bioequivalence and Bioavailability Forum • NCA with bear?

NCA with bear? [RSABE / ABEL]

posted by yjlee168 – Kaohsiung, Taiwan, 2015-03-09 16:24 (3329 d 02:03 ago) – Posting: # 14555
Views: 26,747

Dear Astea,

❝ [...] But if it is so, why can't we use NCA data received manually for the latest statistical analyses in BEAR?

❝ I tried to use NCA data contained unequal numbers of subjects in different periods and BEAR didn't show errors while doing statistics.

❝ For example, we omit one of the period from the study for the N'th subject. Will the statistics compilated by BEAR be correct in such a case?

Really? I have no idea right now. No error with omitting one of the periods from a subject? I am not sure about that. A very good question.

❝ By the way, what is the reason for which BEAR couldn't calculate NCA for subjects with all zero concentrations in one of the period? In my mind, all individual pharmacokinetic parameters should be calculated independently for each period? :confused:

You are right about the procedures of NCA. However, when doing NCA, it also calculates some other parameters. For example, clearance (CL) is calculated with Dose*F/AUC_0-inf. For all zero concentrations, AUC_0-inf is zero. So it crashes. Also to estimate the terminal phase elimination rate constants (k_el), it requires none-zero data from terminal phase to perform linear regression (to get a slope). It certainly stops the run at this step too.

❝ And the last question: am I right when thinking that for calculation CI of Cmax/AUC0t I can simply change the columns AUC0INF and lnAUCOINF for Cmax/AUC0t and ln Cmax/AUC0t respectively?

Smart way. It should work well. You have to remember to change the name of parameters with all output files.

—
All the best,
-- Yung-jin Lee
bear v2.9.1:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here

Complete thread:

Statistical Analysis section of partial replicate BE study cher0424 2015-01-07 06:39 [RSABE / ABEL]
- Subjects to be considered in partial replicate BE study d_labes 2015-01-07 14:45
  - Subjects to be considered in partial replicate BE study cher0424 2015-01-07 15:35
  - Subjects to be considered in partial replicate BE study cher0424 2015-01-08 06:28
    - Subjects to be considered in partial replicate BE study d_labes 2015-01-08 09:03
      - Subjects to be considered in partial replicate BE study cher0424 2015-01-08 09:51
        
        Subjects to be considered in partial replicate BE study d_labes 2015-01-08 10:27
        
        Subjects in replicate BE study EU/FDA Shuanghe 2015-01-08 11:08
        
        Subjects in replicate BE study EU/FDA cher0424 2015-01-08 13:56
        Subjects in replicate BE study EU/FDA Relaxation 2015-03-02 09:46
        
        Subjects in replicate BE study EU/FDA d_labes 2015-03-02 11:38
        Subjects in replicate BE study EU mittyri 2015-03-19 20:12
  - Subjects to be considered in partial replicate BE study Dr_Dan 2015-01-08 08:59
    - Subjects to be considered in partial replicate BE study d_labes 2015-01-08 09:04
      - Subjects to be considered in partial replicate BE study Astea 2015-03-01 18:12
        
        Subjects to be considered in partial replicate BE study yjlee168 2015-03-01 19:01
        
        Subjects to be considered in partial replicate BE study Astea 2015-03-09 14:43
        
        NCA with bear?yjlee168 2015-03-09 15:24
        
        Bear and null PK parameters mittyri 2015-03-25 09:50
        
        to exclude or not to exclude the subjects with bear? yjlee168 2015-03-28 21:03
        
        to exclude or not to exclude - let the user decide mittyri 2015-03-29 19:04
        
        to exclude or not to exclude - let the user decide yjlee168 2015-03-30 11:28
        
        to exclude or not to exclude - let the user decide ElMaestro 2015-03-30 15:44
        
        to exclude or not to exclude - let the user decide yjlee168 2015-03-31 11:15
        
        Constraints, algebra, jommetry and such ElMaestro 2015-03-31 12:16
        
        Constraints, algebra, jommetry and such yjlee168 2015-03-31 13:13
        
        Constraints, algebra, jommetry and such ElMaestro 2015-03-31 14:26
        
        Constraints, algebra, jommetry and such mittyri 2015-04-01 08:25
        
        Proc GLM, lm() do not auto-exclude subjects d_labes 2015-04-01 09:15
        
        Proc GLM, lm() do not auto-exclude subjects ElMaestro 2015-04-01 16:29