ElMaestro
★★★

Denmark,
2018-08-15 13:02
(2520 d 23:57 ago)

Posting: # 19169
Views: 4,213
 

 Spelling out FDA's pop BE model [General Sta­tis­tics]

Dear all,

I am trying to spell out the underlying model of FDA's pop BE analysis used for in vitro comparison of signle actuator content and more. A link is here.

The players are:

The formulations (F, two levels)
The stages (S, three levels in FDA's example, but may be anything from one upwards)
The cans ("Cans in batch", C, at least ten levels)
The batches ("batch within formulation", B, at least three levels)

I was initially thinking
Y=F+S+C+B+ek where ek is N(0, MSWk), and where Y is the in vitro metric we are sampling, like SAC, and where we's consider C, possibly B and S random (?).

But since MSWk comes from sampling across stages, I am inclined to work without S, so
a. Y=F+C+B+ek,
where C and possibly B are random. When there is only a single sampled stage I guess this would then be
b. Y=F+B+ek where ek is then N(0, MSBk)

What's your opinion on a. and b.?
How would you formulate the models yourself?

Pass or fail!
ElMaestro
nobody
nothing

2018-08-17 11:18
(2519 d 01:41 ago)

@ ElMaestro
Posting: # 19170
Views: 3,381
 

 Spelling out FDA's pop BE model

...maybe a post to the NONMEM users would be an option?

[email protected]

;-)

Kindest regards, nobody
UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,684 registered users;
25 visitors (0 registered, 25 guests [including 4 identified bots]).
Forum time: 12:59 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5