## 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+e

But since MSW

a. Y=F+C+B+e

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+e

What's your opinion on a. and b.?

How would

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+e

_{k}where e_{k}is N(0, MSW_{k}), 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 MSW

_{k}comes from sampling across stages, I am inclined to work without S, soa. Y=F+C+B+e

_{k},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+e

_{k}where e_{k}is then N(0, MSB_{k})What's your opinion on a. and b.?

How would

*you*formulate the models yourself?—

Pass or fail!

ElMaestro

Pass or fail!

ElMaestro

### Complete thread:

- Spelling out FDA's pop BE modelElMaestro 2018-08-15 11:02 [General Statistics]
- Spelling out FDA's pop BE model nobody 2018-08-17 09:18