Bioequivalence and Bioavailability Forum • Suggestion

Suggestion [🇷 for BE/BA]

posted by Helmut – Vienna, Austria, 2015-12-07 15:01 (3059 d 23:46 ago) – Posting: # 15703
Views: 27,962

Hi Yung-jin,

❝ ❝ [...] In a future version, could you add an option to generate randomisation schemes for the various BE designs?

❝

❝ […] It's a really great idea. I will put this into the top of to-do-list.

One option is to include Detlew’s package randomizeBE as a dependency when building the package. Then you don’t have to re-invent the wheel and only need to handle the in-/output within bear.

❝ The other one is considering BE dataset simulation based on the in-vitro dissolution profile and PBPK (IVIVC + PBPK -> IVIVE??).

Wow!

❝ Also there is a TSD waiting for years...

According to EMA’s Q&A (Rev.7 of 2013-02-13) the model for the final analysis (pooled data) is:
stage, sequence, sequence × stage, subject(sequence × stage), period(stage), formulation.

—
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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
- Suggestion ElMaestro 2015-12-07 10:12
  - Suggestion yjlee168 2015-12-07 10:55
    - SuggestionHelmut 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