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Locke's method for bioequivalence evaluation of topical dermtologic corticosteroids

Lockes method Locke topical corticosteroids oitment crem

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#1 Veronika Trushko

Veronika Trushko

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Posted 23 November 2018 - 09:11 AM

Hello everyone,
I have question about Locke's method for bioequivalence evaluation of topical dermtologic corticosteroids that is suggested by FDA. It described in the guidance (check attached file) in appendix V on pages 38-39. Maybe someone had experience with it? How it can be realised in Phoenix Winnonlin?

Best regards, Veronika.

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Edited by Simon Davis, 23 November 2018 - 09:26 AM.

Best regards,

Veronika


#2 Simon Davis

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Posted 27 November 2018 - 03:26 PM

Hi Veronika, this methodology isn't currently supported in Phoenix as an 'off the shelf' function, but is already noted as something our users are interested in;

 

QC4871 – “Confidence intervals (CI)  according to Fieller's theorem or Locke's Method (or Bailer-Satterwaite)”

 

.  However it could be currently  written/run as a workflow within Phoenix if that is of interest to you?

 

 Simon.



#3 Veronika Trushko

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Posted 28 November 2018 - 05:58 AM

Hello Simon, thank for your reply.

If it could be written/run as a workflow within Phoenix, it would be interesting for me how to make it. Look forward to your reply.

 

Veronika.


Best regards,

Veronika


#4 Simon Davis

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Posted 28 November 2018 - 01:51 PM

Hi Veronkia,

   Here is an example project; it's not an 'official' solution as it hasn't been QC'ed etc but it may help as a basis for your workflow.

 

 SImon.

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Edited by Simon Davis, 28 November 2018 - 01:53 PM.


#5 Veronika Trushko

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Posted 29 November 2018 - 06:05 AM

Thank you so much for your help, Simon!
 

Best wishes, Veronika.


Best regards,

Veronika





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