mahmoud-teaima
★    

2016-08-25 23:56
(3164 d 07:34 ago)

Posting: # 16577
Views: 6,183
 

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

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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
(3163 d 21:00 ago)

@ mahmoud-teaima
Posting: # 16578
Views: 5,124
 

 Validation of bear 2.7.5 in R 3.3.1 on macos10.11.6

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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 v2.9.2:- 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
(3163 d 13:36 ago)

@ yjlee168
Posting: # 16592
Views: 5,080
 

 Validation of bear 2.7.5 in R 3.3.1 on macos10.11.6

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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
(3163 d 18:10 ago)

@ mahmoud-teaima
Posting: # 16582
Views: 5,211
 

 Validation of software for BE

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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 , Detlew 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 , Detlew 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.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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mahmoud-teaima
★    

2016-08-26 17:53
(3163 d 13:37 ago)

@ Helmut
Posting: # 16591
Views: 5,056
 

 Validation of software for BE

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Dear Helmut
Many thanks for your help.
Appreciate it a lot.
Wish you the best.
—
Mahmoud Teaima, PhD.
 
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