mahmoud-teaima
★    

2016-08-25 23:56
(2772 d 00:54 ago)

Posting: # 16577
Views: 5,477
 

 Validation of bear 2.7.5 in R 3.3.1 on macos10.11.6 [🇷 for BE/BA]

Dear all,
I have submitted a report for a BE study to our local regulatory authority. I used for calculations bear 2.7.5 in R 3.3.1 running on macos 10.11.6 Elcaptin; but they want a validation proof for that package and program.
Can anyone of our forum experts advise me on how to supply the proof for that request.

Thanks all for help.

Greetings.

Mahmoud Teaima, PhD.
yjlee168
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Homepage
Kaohsiung, Taiwan,
2016-08-26 10:29
(2771 d 14:20 ago)

@ mahmoud-teaima
Posting: # 16578
Views: 4,580
 

 Validation of bear 2.7.5 in R 3.3.1 on macos10.11.6

Dear Mahmound,

I don't know if this file can help or not. Good luck. --YJ

❝ ... I used for calculations bear 2.7.5 in R 3.3.1 running on macos 10.11.6 Elcaptin; but they want a validation proof for that package and program.


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
mahmoud-teaima
★    

2016-08-26 17:54
(2771 d 06:55 ago)

@ yjlee168
Posting: # 16592
Views: 4,559
 

 Validation of bear 2.7.5 in R 3.3.1 on macos10.11.6

Dear YJLee,I appreciate your help a lot.
Many thanks.
Wish you the best.

Mahmoud Teaima, PhD.
Helmut
★★★
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Homepage
Vienna, Austria,
2016-08-26 13:20
(2771 d 11:30 ago)

@ mahmoud-teaima
Posting: # 16582
Views: 4,631
 

 Validation of software for BE

Salam Mahmoud,

❝ […] our local regulatory authority […] want a validation proof for that package and program.


Understandable after the Kinetica-disaster (which was very popular in the Middle East).

❝ Can anyone of our forum experts advise me on how to supply the proof for that request.


I suggest to compare bear’s results with the ones in other software packages. We published two papers on the topic in order to support users in validation.1,2 Following the PMC-links in PubMed the reference datasets are available.

Good luck!


  1. Schütz H, Labes D, Fuglsang A. Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies. AAPS J. 2014;16(6):1292–7. doi:10.1208/s12248-014-9661-0. PMID 25212768. [image] free resource.
  2. Fuglsang A, Schütz H, Labes D. Reference Datasets for Bioequivalence Trials in a Two-Group Parallel Design. AAPS J. 2015;17(2):400–4. doi:10.1208/s12248-014-9704-6. PMID 25488055. [image] free resource.

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mahmoud-teaima
★    

2016-08-26 17:53
(2771 d 06:57 ago)

@ Helmut
Posting: # 16591
Views: 4,519
 

 Validation of software for BE

Dear Helmut
Many thanks for your help.
Appreciate it a lot.
Wish you the best.

Mahmoud Teaima, PhD.
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