scorp2011
☆    

India,
2015-04-01 08:12
(3284 d 15:05 ago)

Posting: # 14644
Views: 6,991
 

 PK model for 2-group BE study in Phoenix Winnonlin 6.3 [Software]

Dear Members,
I have the below listed query:

Whether it is possible to calculate BE parameters for a 2-group 2-Period Crossover BE study in Phoenix Winnonlin 6.3. If yes, kindly share the step by step procedure.

Thanks in advance.

Regards
Sonu


Edit: Category changed. [Helmut]
mittyri
★★  

Russia,
2015-04-01 09:06
(3284 d 14:10 ago)

@ scorp2011
Posting: # 14645
Views: 6,086
 

 PK model for 2-group BE study in Phoenix Winnonlin 6.3

Dear Sonu,

I'm little bit bewildered: did you read the user's guide for Phoenix? It's included to the main program. Also you can find there some examples.
By the way you can find one great template on this forum. Very detailed instruction is also presented.

Kind regards,
Mittyri
scorp2011
☆    

India,
2015-04-01 10:28
(3284 d 12:48 ago)

@ mittyri
Posting: # 14648
Views: 5,954
 

 PK model for 2-group BE study in Phoenix Winnonlin 6.3

Dear Sir,
Thanks for the prompt response.
I am a bit confused now and I am now trying to be little clear with query.

A crossover BE study conducted in two groups due to logistical reasons.
In group I, 18 subjects were dosed.
In group II, another 18 subjects dosed.
My question is whether there is a provision in Phoenix Winnonlin 6.3 to analyze the group effect. If group effect is found significant, can we calculate bioequivalence parameters after including this group effect in Winnonlin 6.3 after including group effect in fixed variance or any other effects,


Regards
Sonu
mittyri
★★  

Russia,
2015-04-01 10:48
(3284 d 12:28 ago)

@ scorp2011
Posting: # 14650
Views: 5,893
 

 PK model for 2-group BE study in Phoenix Win­non­lin 6.3

Dear Sonu,

You can modify the model before executing the BEQ module by including the group effect. The information about the group belonging for each subject should be added accordingly.
The ANOVA results will show the significance of all effects.

Kind regards,
Mittyri
scorp2011
☆    

India,
2015-04-01 11:37
(3284 d 11:39 ago)

@ mittyri
Posting: # 14652
Views: 5,860
 

 PK model for 2-group BE study in Phoenix Win­non­lin 6.3

Dear Sir,
I am unable to find the procedure.
Request you to please see if you can kindly share the procedure to include the group effect.
Regards
Sonu
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2015-04-01 15:34
(3284 d 07:42 ago)

@ scorp2011
Posting: # 14653
Views: 5,950
 

 BE model for 2-group Xover in Phoenix Win­Non­lin 6.x

Hi Sonu,

❝ A crossover BE study conducted in two groups due to logistical reasons.

❝ In group I, 18 subjects were dosed.

❝ In group II, another 18 subjects dosed.


You used the past tense. For the future it might be a good idea not to perform a study if you don’t know how to analyze it. The model(s) and procedures should be stated in the clinical pro­to­col and/or SAP.

❝ My question is whether there is a provision in Phoenix Winnonlin 6.3 to analyze the group effect.


Sure – RTFM: Section ‘Bioequivalence’ and details about specifying effects in section ‘Linear Mixed Effects Modeling’.

❝ If group effect is found significant, can we calculate bioequivalence parameters after including this group effect in Winnonlin 6.3 after including group effect in fixed variance or any other effects,


Whether you include a group-term or not does not affect the residual error. Therefore, the PE and CI will be identical in both cases. For a discussion see this thread.

If you are unsure about the setup, register at Certara’s Forum where you could upload your project-file.


PS: I suggest to update to Phoenix/WinNonlin 6.4 (released last November).

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