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

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

posted by Helmut – Vienna, Austria, 2015-12-16 02:45 (3387 d 13:54 ago) – Posting: # 15735
Views: 28,008

Dear Yung-jin, Astea, and all others,

❝ 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.

Strong agree.

❝ 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?

Yep, very likely they are. See these threads: #14584, #14925, #10603, #4182. I like Simon’s term “embedded BQLs”. I think that is very difficult for a silicon-based life form to guess which PK may underly such profiles. The easiest way to avoid them is a more sensitive bioanalytical method… I know, I know. Shit happens. Whatever one chooses to do – it should be done consistently across all subjects and treatments. Sorry for no better news. Don’t blame the messenger.

—
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Helmut Schütz

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Science Quotes

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