Helmut
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2016-07-07 15:16
(2821 d 21:39 ago)

Posting: # 16473
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 FDA: Budesonide in vitro PBE [Power / Sample Size]

Dear all,

does anybody know how to estimate the sample size for the FDA’s in vitro PBE of budesonide? I’m completely lost…

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BE-proff
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2016-07-07 15:36
(2821 d 21:18 ago)

@ Helmut
Posting: # 16474
Views: 7,020
 

 FDA: Budesonide in vitro PBE

Hi Helmut,

I think the option is to request FDA how to do it.
They are responsive guys so they will hardly refuse you ))
Helmut
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2016-07-07 15:44
(2821 d 21:10 ago)

@ BE-proff
Posting: # 16475
Views: 7,005
 

 asking the FDA…

Hi BE-proff

❝ I think the option is to request FDA how to do it.

❝ They are responsive guys so they will hardly refuse you ))


I would not bet on that. F.i. the FDA’s SAS-code for ABE in the partial replicate design (if no scaling is applied) fails to converge due to the over-specified model (regardless which software one uses). John sent a letter to Donald Schuirmann asking for a clarification and never received an answer. :-(

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ElMaestro
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Denmark,
2016-07-07 15:57
(2821 d 20:57 ago)

@ Helmut
Posting: # 16476
Views: 6,932
 

 FDA: Budesonide in vitro PBE

Hi Hötzi,

I believe you need to set up a resampling/bootstrap method.

This is where communication is of utmost importance. In companies where sample size for BE is of interest, it usually takes 5 minutes and a minimum of googling to get a sample size. Here it will take about 100 hrs of programming time and you cannot validate it because noone has a dataset with known result. Tough sh!t.

Pass or fail!
ElMaestro
Helmut
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2016-07-07 16:12
(2821 d 20:42 ago)

@ ElMaestro
Posting: # 16477
Views: 7,030
 

 FDA: Budesonide in vitro PBE

Hi ElMaestro,

❝ I believe you need to set up a resampling/bootstrap method.


Yes, that was my first idea as well. I have some preliminary data to play with.

❝ […] Here it will take about 100 hrs of programming time and you cannot validate it because noone has a dataset with known result. Tough sh!t.


Yep. At least the guidance contains a dataset.

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mittyri
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Russia,
2016-07-07 16:17
(2821 d 20:37 ago)

@ Helmut
Posting: # 16478
Views: 6,972
 

 FDA: Budesonide in vitro PBE

Hi Helmut,

If I understood correctly, simulation is the best choice, something like this:
Morgan B, Strickland H. Performance Properties of the Population Bioequivalence Approach for In Vitro Delivered Dose for Orally Inhaled Respiratory Products. The AAPS Journal. 2014;16(1):89-100. doi:10.1208/s12248-013-9543-x.

Is that an enhancement request to "Swiss army knife for lazy guys dealing with BE studies"?:-D

Kind regards,
Mittyri
Helmut
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2016-07-07 16:25
(2821 d 20:29 ago)

@ mittyri
Posting: # 16479
Views: 7,057
 

 FDA: Budesonide in vitro PBE

Hi mittyri,

❝ If I understood correctly, simulation is the best choice, something like this […]



THX; looks promising!

❝ Is that an enhancement request to "Swiss army knife for lazy guys dealing with BE studies"?:-D


I wouldn’t say so. IMHO there are other things on the to-do-list with a higher rate of importance. AFAIK this method is required by the FDA only for two products: Budesonide Suspension/Inhalation and Intravenous Iron Sucrose.

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