Bioequivalence and Bioavailability Forum • BLLOQ ≠ 0 with measured drug plasma conc.

BLLOQ ≠ 0 with measured drug plasma conc. [🇷 for BE/BA]

posted by yjlee168 – Kaohsiung, Taiwan, 2015-12-15 21:17 (3387 d 20:24 ago) – Posting: # 15734
Views: 28,041

Dear Astea,

❝ What about zero-samples that are not in the last elimination part of the curve? I mean that theoretically there can be a zero-concentration point between other non-zero values (for example for the drugs with entero-hepatic recirculation)? The result of the calculation would depend on whether this point is marked like "zero" or "NA", wouldn't it?

Good question. Well, theoretically there should be no real zero conc. at all after taking a medicine for a reasonable sampling time period of a BE/BA study. Of course, there may have some conc. below LLOQ, occurring at any time point. I don't quite understand why we will possibly have real zero conc. for the drug undergoing entero-hepatic recirculation. :confused:

Are they just below LLOQ? Could you explain more? Thanks.

—
All the best,
-- Yung-jin Lee
bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here

Complete thread:

bear v2.7.0 released yjlee168 2015-12-07 09:18 [🇷 for BE/BA]
- Suggestion ElMaestro 2015-12-07 10:12
  - Suggestion yjlee168 2015-12-07 10:55
    - Suggestion Helmut 2015-12-07 14:01
      - Suggestion yjlee168 2015-12-07 18:51
- bear v2.7.0 released Astea 2015-12-10 16:36
  - if Clast is zero in bear yjlee168 2015-12-10 17:23
    - if Clast is zero in bear Astea 2015-12-10 20:50
      - if Clast is zero in bear yjlee168 2015-12-11 03:28
        
        if Clast is zero in bear Astea 2015-12-11 09:39
        
        if Clast is zero in bear yjlee168 2015-12-11 17:16
    - bear v2.7.1 yjlee168 2015-12-15 10:21
      - bear v2.7.1 Astea 2015-12-15 19:32
        
        BLLOQ ≠ 0 with measured drug plasma conc.yjlee168 2015-12-15 20:17
        
        BLLOQ ≠ 0 with measured drug plasma conc. Helmut 2015-12-16 01:45
        
        BLLOQ ≠ 0 with measured drug plasma conc. yjlee168 2015-12-16 11:38
        
        BLLOQ ≠ 0 ∀ t > 0 Helmut 2015-12-16 12:40
        
        BLLOQ ∋ { 0, ≈0, BLLOQ{...} ∀ t > 0} yjlee168 2015-12-16 18:22
        
        BLLOQ at first two time ponts, AUC calculation Astea 2016-01-30 17:11
        
        zero-zero with AUC calculation in bear yjlee168 2016-01-30 19:00
        
        BQL rules in bear mittyri 2016-02-01 22:16
        
        BQL rules in bear yjlee168 2016-02-02 10:59
        possible solutions? yjlee168 2016-02-02 21:30
        zero (0), missing (NA), or BLLOQ (0 or NA) in bear yjlee168 2016-02-03 09:04
        
        zero (0), missing (NA), or BLLOQ (0 or NA) in bear mahmoud-teaima 2016-02-08 21:28
        
        Please avoid Full Quotes (“TOFU”)! Ohlbe 2016-02-09 00:51
        
        error message in bear mahmoud-teaima 2016-02-09 04:55
        
        please check your dataset file yjlee168 2016-02-09 06:40
        
        please check your dataset file mahmoud-teaima 2016-02-09 15:00
        
        please check your dataset file yjlee168 2016-02-09 15:38
        
        A possible R bug? yjlee168 2016-02-09 19:14