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RegisterSample Size for Drugs Interaction studies [Power / Sample Size]
Dear Lara!
Some readings:
- Guidances FDA and EMA.
- Book:
STEVEN A. JULIOUS, SAY BENG TAN, DAVID MACHIN
"An Introduction to Statistics in Early Phase Trials"
Chapter 10
After diving into this literature you will detect "It is correct to use BE sample size estimation also for Drugs interaction studies". At least as standard case.
Eventually you have to adapt the BE acceptance range, aka no-effect margin in the context of drug-interaction studies. Quote from the above recommended book: "Depending on the drug(s), a no-effect margin wider (or narrower) than (0.80, 1.25) may be justified ...".
Don't ask me about the justification
.
❝ Hi Helmut,
❝ Question: Is it correct to use BE sample size estimation for Drugs interaction studies?
Some readings:
- Guidances FDA and EMA.
- Book:
STEVEN A. JULIOUS, SAY BENG TAN, DAVID MACHIN
"An Introduction to Statistics in Early Phase Trials"
Chapter 10
After diving into this literature you will detect "It is correct to use BE sample size estimation also for Drugs interaction studies". At least as standard case.
Eventually you have to adapt the BE acceptance range, aka no-effect margin in the context of drug-interaction studies. Quote from the above recommended book: "Depending on the drug(s), a no-effect margin wider (or narrower) than (0.80, 1.25) may be justified ...".
Don't ask me about the justification
.—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Sample Size for Drugs Interaction studies Lara 2015-11-03 23:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sample Size for Drugs Interaction studiesd_labes 2015-11-04 11:12
- Sample Size for Drugs Interaction studies Helmut 2015-11-04 11:17
- Sample Size for Drugs Interaction studies Lara 2015-11-04 18:28
Ing. Helmut Schütz