fixed swr [RSABE / ABEL]
Hi Martin!
Nope. Actually the methods are (hidden) sequential.
Most clear in the FDA’s guidance:
❝ What do you think about a kind of adaptive group-sequential design with one interim analysis (i.e. estimate CV) allowing to make a decision regarding average BE or scaled BE in the final analysis? This may solve the problem.
Nope. Actually the methods are (hidden) sequential.
Most clear in the FDA’s guidance:
Determine sWR, the within-subject standard deviation (SD) of the reference product, for the pharmacokinetic (PK) parameters AUC and Cmax.
- If sWR < 0.294,1,2 use the two one-sided tests procedure to determine bioequivalence (BE) for the individual PK parameter(s)
- If sWR ≥ 0.294,2 use the reference-scaled procedure to determine BE for the individual PK parameter(s)
- sWR 0.294 ~ CVWR 0.300469…
- We see the worst inflation at CVWR 0.3. Maybe it would be better to use ABE if sWR ≤ 0.294 and RSABE if sWR > 0.294.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- ‘alpha’ of scaled ABE? d_labes 2013-03-15 15:56 [RSABE / ABEL]
- ‘alpha’ of scaled ABE? Helmut 2013-03-15 17:27
- ’alpha’ of scaled ABE: design d_labes 2013-03-16 20:10
- N=24, 48 d_labes 2013-03-18 08:11
- adaptive design without adjustment martin 2013-03-25 20:47
- α adjustment? Helmut 2013-03-26 15:21
- iteratively adjusted alpha martin 2013-03-26 16:19
- throw away our sample size tables? Helmut 2013-03-26 18:02
- if real martin 2013-03-26 19:44
- regulators don’t care? Helmut 2013-03-26 21:18
- adjusting α Helmut 2013-08-11 16:19
- if real martin 2013-03-26 19:44
- target α in sim’s? Helmut 2013-03-27 15:38
- target α in sim’s? martin 2013-03-27 16:36
- If it is real: results Helmut 2013-03-28 23:20
- having alpha martin 2013-03-28 15:08
- fixed swrHelmut 2013-03-28 23:34
- fixed swr martin 2013-03-29 15:07
- Yes but no but yes but no but… Helmut 2013-03-29 16:10
- fixed swr martin 2013-03-29 15:07
- fixed swrHelmut 2013-03-28 23:34
- target α in sim’s? martin 2013-03-27 16:36
- throw away our sample size tables? Helmut 2013-03-26 18:02
- iteratively adjusted alpha martin 2013-03-26 16:19
- α adjustment? Helmut 2013-03-26 15:21
- adaptive design without adjustment martin 2013-03-25 20:47
- N=24, 48 d_labes 2013-03-18 08:11
- ’alpha’ of scaled ABE: design d_labes 2013-03-16 20:10
- ‘alpha’ of scaled ABE? Helmut 2013-03-15 17:27