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RegisterPartial replicate designs [RSABE / ABEL]
Good morning Europe (and hello to the rest of you),
I'd like to get you folks' take on something and some informtion on the other.
Thing one (not-so-subtle Dr. Seuss reference! and yes, you guessed it, I have young children).
Okay, what is the advantage of conducting a full replicate BE study on an suspected HVDP if the ability to widen CIs is based solely on the reference product variability (basically, it's cheaper to conduct a partial with RTR/RRT, right?)?
The second thing is the following. What is the sample size estimate for a drug (not Schützomycin) with a intra-subject variability of 37.5%? And how would those subjects be distributed per group in said partial replicate?
Just in case ya'll are wondering. I'm actually not asking ya'll to do my work for me, I'm trying to wrap my head around a concept I don't seem to be able to wrap my head around when I should.
Thank you,
Outlaw Torn
I'd like to get you folks' take on something and some informtion on the other.
Thing one (not-so-subtle Dr. Seuss reference! and yes, you guessed it, I have young children).
Okay, what is the advantage of conducting a full replicate BE study on an suspected HVDP if the ability to widen CIs is based solely on the reference product variability (basically, it's cheaper to conduct a partial with RTR/RRT, right?)?The second thing is the following. What is the sample size estimate for a drug (not Schützomycin) with a intra-subject variability of 37.5%? And how would those subjects be distributed per group in said partial replicate?
Just in case ya'll are wondering. I'm actually not asking ya'll to do my work for me, I'm trying to wrap my head around a concept I don't seem to be able to wrap my head around when I should.
Thank you,
Outlaw Torn
Complete thread:
- Partial replicate designsThe Outlaw Torn 2013-09-25 08:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Partial replicate designs Helmut 2013-09-25 09:12
- Partial replicate designs The Outlaw Torn 2013-09-25 11:10
- Partial replicate designs Helmut 2013-09-25 16:35
- Partial replicate designs The Outlaw Torn 2013-09-26 08:34
- OT Helmut 2013-09-26 08:56
- Partial replicate designs The Outlaw Torn 2013-09-26 08:34
- Partial replicate designs Helmut 2013-09-25 16:35
- Partial replicate designs The Outlaw Torn 2013-09-25 11:10
- Partial replicate designs Helmut 2013-09-25 09:12
Ing. Helmut Schütz