Bioequivalence and Bioavailability Forum • Validation of PhEq

Validation of PhEq_bootstrap [Software]

posted by Rayhope – India, 2021-07-29 10:49 (1232 d 02:50 ago) – Posting: # 22485
Views: 8,753

❝ I was asked whether it is possible to validate PhEq_bootstrap (see this post). Sure. Since the source-code is available and if one is familiar with Object Pascal even a “white-box” validation is doable. :-D

Hi Helmut,
similar query received from agency for validation of PhEq results. Can you help me out with simple steps to do that. I dont know about programming or validation of software. I read all conversations related to your post, I came to conclusion that Validation of PhEq and BootF2CA is not at all my cup of tea. But need to reply on Agency query how to proceed. Please guide me.
Also let me know if you can provide SAS code for bootstrap mentioned in article of Shah et al. (In vitro Dissolution Profile Comparison-statistics and Analysis of similarity Factor F2, Pharmaceutical Research Vol 15, no.6 1998).
Disclaimer: I don't have any basic knowledge of Coding in any language.

Complete thread:

Validation of PhEq_bootstrap Helmut 2018-07-12 17:47 [Software]
- Validation of PhEq_bootstrap ElMaestro 2018-07-12 22:21
  - Validation of PhEq_bootstrap Helmut 2018-07-13 01:29
    - Validation of PhEq_bootstrap ElMaestro 2018-07-13 10:14
      - Validation of PhEq_bootstrap Helmut 2018-07-13 12:54
        
        Validation of PhEq_bootstrap ElMaestro 2018-07-13 14:28
- Validation of PhEq_bootstrap Shuanghe 2018-07-17 15:54
- PhEq_bootstrap in R d_labes 2018-08-15 09:45
  - bootf2BCA v1.1 Helmut 2019-10-05 00:59
    - bootf2BCA v1.2: seed Helmut 2020-09-25 19:37
      - bootf2BCA v1.2: seed PTM139 2021-04-16 07:53
        
        Which packages, working directory? Helmut 2021-04-16 10:50
        
        Which packages, working directory? PTM139 2021-04-27 13:02
      - bootf2BCA v1.2: seed Rayhope 2022-03-28 14:35
        
        bootf2BCA v1.3 Helmut 2022-03-28 14:48
        
        bootf2BCA v1.3 Rayhope 2022-03-30 06:34
    - bootf2BCA v1.1 Flam 2023-06-21 03:41
      - bootf2BCA v1.3.1 (current since 2022-06-25) Helmut 2023-06-23 13:47
        
        bootf2BCA v1.3.1 (current since 2022-06-25) Flam 2023-06-26 23:16
        
        Install required packages first Helmut 2023-06-27 11:47
- Validation of PhEq_bootstrapRayhope 2021-07-29 08:49
  - Validation of PhEq_bootstrap Helmut 2021-08-02 18:12