Bioequivalence and Bioavailability Forum

BE = CI within acceptance range (PE is irrelevant) [Power / Sample Size]

posted by kimhuang – China, 2025-10-16 11:37 (244 d 00:06 ago) – Posting: # 24462
Views: 2,755

Dear ElMaestro,

❝ here's an example, I think:

❝ https://www.fda.gov/media/166738/download

Thank you very much for sharing this case. It has just completely removed my concerns.

❝ Read carefully, sometimes a sentence needs to be read more than once before a meaning transpires – so it is at least for me

is this sentence "Reformulate the proposed product and conduct additional relative bioavailability studies to demonstrate the bioequivalence to the listed drug or conduct a clinical study to support the effective and safe use of the proposed atorvastatin oral suspension product." meaningful?

Best Regards!

Complete thread:

• Point Estimate consideration in sample size estimate kimhuang 2025-10-09 07:21 
  • Point Estimate consideration in sample size estimate Helmut 2025-10-14 12:33
    • Point Estimate consideration in sample size estimate kimhuang 2025-10-15 00:53
      • BE = CI within acceptance range (PE is irrelevant) Helmut 2025-10-15 09:32
        • BE = CI within acceptance range (PE is irrelevant) ElMaestro 2025-10-15 10:07
          • BE = CI within acceptance range (PE is irrelevant)kimhuang 2025-10-16 09:37
        • BE = CI within acceptance range (PE is irrelevant) kimhuang 2025-10-16 08:26