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Back to the forum  Query: 2017-11-18 13:02 CET (UTC+1h)
 
mahmoud-teaima
Regular

Cairo, Egypt,
2016-08-25 21:56

Posting: # 16577
Views: 2,371
 

 Validation of bear 2.7.5 in R 3.3.1 on macos10.11.6 [R 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.
Assistant Professor at Department of Pharmaceutics and Industrial Pharmacy.
Vice-director at Center of Applied Research and Advanced Studies (CARAS).
Faculty of Pharmacy, Cairo University, Cairo, Egypt.
yjlee168
Senior
Homepage
Kaohsiung, Taiwan,
2016-08-26 08:29

@ mahmoud-teaima
Posting: # 16578
Views: 1,920
 

 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
[image]bear v2.8.3:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan http://pkpd.kmu.edu.tw/bear
Download link (updated) -> here
mahmoud-teaima
Regular

Cairo, Egypt,
2016-08-26 15:54

@ yjlee168
Posting: # 16592
Views: 1,880
 

 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.
Assistant Professor at Department of Pharmaceutics and Industrial Pharmacy.
Vice-director at Center of Applied Research and Advanced Studies (CARAS).
Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Helmut
Hero
Homepage
Vienna, Austria,
2016-08-26 11:20

@ mahmoud-teaima
Posting: # 16582
Views: 1,899
 

 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 PubMed-links the full text is available for free as are the reference datasets.

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. Free view-only version.
  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. Free view-only version.

[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
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mahmoud-teaima
Regular

Cairo, Egypt,
2016-08-26 15:53

@ Helmut
Posting: # 16591
Views: 1,856
 

 Validation of software for BE

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

Mahmoud Teaima, PhD.
Assistant Professor at Department of Pharmaceutics and Industrial Pharmacy.
Vice-director at Center of Applied Research and Advanced Studies (CARAS).
Faculty of Pharmacy, Cairo University, Cairo, Egypt.
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