Issue with PBE Calculation when Stage = 1 [Regulatives / Guidelines]
FDA “Draft Guidance on Budesonide” part 5, provides Recommendation Related to the Population Bioequivalence (PBE) Statistical Analysis Procedure (Step 3):
a. If SigmaR is greater than 0.1, the reference-scaled procedure should be used.
b. If SigmaR is less or equal to 0.1, then the constant-scaled procedure should be used.
However, when stage (m) is 1, SigmaR cannot be defined because the calculation for MSWk cannot proceed when m = 1 (see formula for MSWk in the guidance).
![[image]](img/uploaded/image916.png)
![[image]](img/uploaded/image917.png)
What approach should be used to calculate PBE when m = 1? Are there any alternative methods or approaches recommended in this scenario?
I have attached formula from Draft Guidance on Budesonide for reference.
Thanks for replying and suggesting!
a. If SigmaR is greater than 0.1, the reference-scaled procedure should be used.
b. If SigmaR is less or equal to 0.1, then the constant-scaled procedure should be used.
However, when stage (m) is 1, SigmaR cannot be defined because the calculation for MSWk cannot proceed when m = 1 (see formula for MSWk in the guidance).
![[image]](img/uploaded/image916.png)
![[image]](img/uploaded/image917.png)
What approach should be used to calculate PBE when m = 1? Are there any alternative methods or approaches recommended in this scenario?
I have attached formula from Draft Guidance on Budesonide for reference.
Thanks for replying and suggesting!
Complete thread:
- Issue with PBE Calculation when Stage = 1weiguo2122 2025-01-13 20:19 [Regulatives / Guidelines]
- Issue with PBE Calculation when Stage = 1 ElMaestro 2025-01-13 21:08
- Issue with PBE Calculation when Stage = 1 weiguo2122 2025-01-15 20:45
- Issue with PBE Calculation when Stage = 1 ElMaestro 2025-01-13 21:08