Imph
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Algeria,
2023-02-12 09:31
(40 d 20:49 ago)

Posting: # 23457
Views: 695
 

 Pharmacokinetic and statistical analysis in bioequivalence while maintaining the blind [General Sta­tis­tics]

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
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Vienna, Austria,
2023-02-12 09:45
(40 d 20:35 ago)

@ Imph
Posting: # 23458
Views: 609
 

 Blinded NCA in Phoenix/WinNonlin

Hi Imph,

❝ In bioequivalence studies, is there a way to keep the blind on the analysts in charge of the pharmacokinetic and statistical analysis ?

Yes and no.

❝ If so, is there a possibility of launching an NCA and bioequivalence analysis on the Phoenix WinNonlin software while maintaining the blind.

Sure – that’s the way I do it for years. In the NCA setup Sort by subject, period. Once you are done, Merge or Join the results with the randomization-table.

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Imph
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Algeria,
2023-02-12 10:08
(40 d 20:12 ago)

@ Helmut
Posting: # 23459
Views: 606
 

 Blinded NCA in Phoenix/WinNonlin

Thank you for the response.

May I clarify that by the blind, I mean a blind on the treatment taken test or reference.
Helmut
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2023-02-12 10:21
(40 d 20:00 ago)

@ Imph
Posting: # 23460
Views: 596
 

 Blinded NCA in Phoenix/WinNonlin

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 Join:
Worksheet 1 (NCA.Final Parameters Pivoted)

[image]

Worksheet 2 (Randomization)

[image]

Gives:

[image]


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ElMaestro
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Denmark,
2023-02-13 16:07
(39 d 14:13 ago)

@ Imph
Posting: # 23461
Views: 530
 

 Pharmacokinetic and statistical analysis in bioequivalence while maintaining the blind

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
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Vienna, Austria,
2023-02-13 17:08
(39 d 13:12 ago)

@ ElMaestro
Posting: # 23462
Views: 557
 

 Phoenix: Locked Workflows

Hi ElMeastro,

❝ What an […] atypical question.

:-D

❝ If WNL can be run from command line (why shouldn't it?) …


That’s not (officially :waving:) 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:

[image]

Once NCA is performed in a blinded manner, lock it and proceed as usual (import the randomization, unblind data, BE).

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Imph
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Algeria,
2023-02-14 14:51
(38 d 15:29 ago)

@ Helmut
Posting: # 23463
Views: 477
 

 Phoenix: Locked Workflows

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:

[image]
Helmut
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Vienna, Austria,
2023-02-14 15:00
(38 d 15:20 ago)

@ Imph
Posting: # 23464
Views: 468
 

 Blind forever?

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:

[image]


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. :cool:

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Imph
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Algeria,
2023-02-15 12:00
(37 d 18:20 ago)

@ Helmut
Posting: # 23466
Views: 433
 

 Blind forever?

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. :cool:


I understand by this that it is impossible :no:
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