Reference? [RSABE / ABEL]
Hi pash,
Do you have a reference? I only know the archived notice Detlew mentioned. The FDA’s model sometimes fails to converge for data of the partial replicate design. Either use one of the full replicates designs (RTRT|TRTR or RTR|TRT) instead or change the random section where the structure of the variance-covariance matrix is specified from
❝ For HVD drugs recently Canada regulatory has published a notice proposing to adopt an average bioequivalence approach to HVDP with expanding limits based on the within-subject variability of the reference product.
Do you have a reference? I only know the archived notice Detlew mentioned. The FDA’s model sometimes fails to converge for data of the partial replicate design. Either use one of the full replicates designs (RTRT|TRTR or RTR|TRT) instead or change the random section where the structure of the variance-covariance matrix is specified from
FA0(2)
to FA0(1)
.—
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Statistical Model for HVD Canada Regulatory pash413 2016-04-04 16:01 [RSABE / ABEL]
- Statistical model for replicate designs Canada d_labes 2016-04-05 13:04
- Statistical model for replicate designs Canada pash413 2016-04-05 13:14
- Reference?Helmut 2016-04-09 14:24
- Statistical model for replicate designs Canada d_labes 2016-04-05 13:04