Imph ★ 2023-02-12 09:31 (669 d 02:52 ago) Posting: # 23457 Views: 3,937 |
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Hello! In bioequivalence studies, is there a way to keep the blind on the analysts in charge of the pharmacokinetic and statistical analysis ? If so, is there a possibility of launching an NCA and bioequivalence analysis on the Phoenix WinNonlin software while maintaining the blind. Thank you in advance. |
Helmut ★★★ Vienna, Austria, 2023-02-12 09:45 (669 d 02:38 ago) @ Imph Posting: # 23458 Views: 3,395 |
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Hi Imph, ❝ In bioequivalence studies, is there a way to keep the blind on the analysts in charge of the pharmacokinetic and statistical analysis ? ❝ If so, is there a possibility of launching an NCA and bioequivalence analysis on the Phoenix WinNonlin software while maintaining the blind. subject, period . Once you are done, or the results with the randomization-table.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Imph ★ 2023-02-12 10:08 (669 d 02:15 ago) @ Helmut Posting: # 23459 Views: 3,299 |
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Thank you for the response. May I clarify that by the blind, I mean a blind on the treatment taken test or reference. |
Helmut ★★★ Vienna, Austria, 2023-02-12 10:21 (669 d 02:03 ago) @ Imph Posting: # 23460 Views: 3,306 |
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Hi Imph, ❝ May I clarify that by the blind, I mean a blind on the treatment taken test or reference. So do I. Once you performed the NCA (sorted by subject and period ), in the :Worksheet 1 (NCA.Final Parameters Pivoted) Worksheet 2 (Randomization) Gives:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
ElMaestro ★★★ Denmark, 2023-02-13 16:07 (667 d 20:16 ago) @ Imph Posting: # 23461 Views: 3,291 |
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Hi Imph, ❝ In bioequivalence studies, is there a way to keep the blind on the analysts in charge of the pharmacokinetic and statistical analysis ? If so, is there a possibility of launching an NCA and bioequivalence analysis on the Phoenix WinNonlin software while maintaining the blind. What an interesting and atypical question. Thank you. I do no know about WinNonlin at all, but this detail aside the matter poses no particular difficulties. You could have an automated process started by a project manager (or whoever ) where stats software queries the PK listing along with the rand. code from separate locations, processes the data and saves the outcome without the statistical or the PK staff even knowing it has taken place. If WNL can be run from command line (why shouldn't it?) then all this is will be fairly easy to do: Person A saves bioanalytical data in folder X. Write access only. Person B saves Rand Code in folder Y. Write access only. Person C shell executes WNL (read access to X and Y) to reconcile PK data with RC, and run the analyses and saving it in location Z while revoking A+B writing credentials (write access). This could be a very, very safe and advantageous approach (one that even could be combined with signal detection etc). But of course if there is an issue with the files and WNL is stuck, then some intervention could be needed. — Pass or fail! ElMaestro |
Helmut ★★★ Vienna, Austria, 2023-02-13 17:08 (667 d 19:15 ago) @ ElMaestro Posting: # 23462 Views: 3,277 |
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Hi ElMeastro, ❝ What an […] atypical question. ❝ If WNL can be run from command line (why shouldn't it?) … That’s not (officially ) supported by Certara. Only ‘classical’ WinNonlin (up to v5.3) had a dedicated command language. Was removed when WNL was integrated in Phoenix v6.0 in 2009. However, there is an option to ‘lock’ workflows within a project-file: Once NCA is performed in a blinded manner, lock it and proceed as usual (import the randomization, unblind data, BE). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Imph ★ 2023-02-14 14:51 (666 d 21:32 ago) @ Helmut Posting: # 23463 Views: 3,194 |
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Hello Thank you for the quick response. Can we join the randomization worksheet on a locked NCA workflow? Once NCA done, is there a way to maintain the blind on the treatment (T/R) when launching BE analysis and escaping the "Reference Formulation" step as shown in: |
Helmut ★★★ Vienna, Austria, 2023-02-14 15:00 (666 d 21:23 ago) @ Imph Posting: # 23464 Views: 3,139 |
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Hi Imph, ❝ Can we join the randomization worksheet on a locked NCA workflow? I think so. Try it yourself. ❝ Once NCA done, is there a way to maintain the blind on the treatment (T/R) when launching BE analysis and escaping the "Reference Formulation" step as shown in: ❝ A mathematician is a blind man Meditate about it. I’m sure you will find the answer yourself. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Imph ★ 2023-02-15 12:00 (666 d 00:23 ago) @ Helmut Posting: # 23466 Views: 3,170 |
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Hello Thanks for taking the time to respond. ❝ I think so. Try it yourself. Indeed, I've tried but in vain, I couldn't find a way to do it. ❝ A mathematician is a blind man ❝ in a dark room looking for a black cat ❝ which isn’t there. Attributed to Charles Darwin ❝ Meditate about it. I’m sure you will find the answer yourself. I understand by this that it is impossible |