Bioequivalence and Bioavailability Forum

1–β not necessarily = Δ [Study Assessment]

posted by Helmut – Vienna, Austria, 2012-10-11 15:05 (4596 d 05:11 ago) – Posting: # 9389
Views: 10,022

Dear Dan!

❝ 2. Power (%): the least statistical power to detect (1-Power) differences between the Test and the Reference formulation.

Not necessarily. The regulatory BE limits in the general case are based on a 20% difference Δ [where BE_lower = 1–Δ and BE_upper=(1–Δ)^-1], which is not related to the producer’s risk (β). The fact that with 80% power both the producer’s risk and the difference to detect are 20% is just coincidental.

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Helmut Schütz

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Complete thread:

Failure of BE in fasting studies ABE1580 2012-10-09 15:42
- Failure of BE in fasting studies drgunasakaran1 2012-10-09 20:07
  - Failure of BE in fasting studies cakhatri 2012-10-10 07:34
    - Failure of BE in fasting studies Dr_Dan 2012-10-10 13:09
    - Different designs: why not? Helmut 2012-10-10 13:48
      - Different designs: why not? cakhatri 2012-10-12 10:42
    - Failure of BE in fasting studies drgunasakaran1 2012-10-10 19:14
      - Failure of BE in fasting studies ABE1580 2012-10-11 06:10
  - Failure of BE in fasting studies drsinghs 2012-10-11 09:28
    - Failure of BE in fasting studies Dr_Dan 2012-10-11 11:43
      - 1–β not necessarily = ΔHelmut 2012-10-11 13:05
      - Sample size d_labes 2012-10-11 13:10
        
        +partial replicate Helmut 2012-10-11 17:53

1–β not necessarily = Δ [Study As­sess­ment]

Complete thread:

1–β not necessarily = Δ [Study Assessment]