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RegisterImmunoglobulins, normal human, for intravascular [Power / Sample Size]
Dear Yura
In a non-controlled (non-comparative) study no control/comparative group (in which subjects are given comparator drug) is used. Is it this what you mean? Pilot study for Proof-of-Concept to evaluate if some Parameters change?
This would be an exploratory study and no formal sample size calculation would be needed. If you want to assess treatment efficacy you need to compare to something (placebo, comparator drug or no treatment at all) and for such a (confirmatory) study you can make a sample size calculation based on the desired outcome (non-inferiority, equivalence or superiority). Please advise.
Kind regards
Dr_Dan
In a non-controlled (non-comparative) study no control/comparative group (in which subjects are given comparator drug) is used. Is it this what you mean? Pilot study for Proof-of-Concept to evaluate if some Parameters change?
This would be an exploratory study and no formal sample size calculation would be needed. If you want to assess treatment efficacy you need to compare to something (placebo, comparator drug or no treatment at all) and for such a (confirmatory) study you can make a sample size calculation based on the desired outcome (non-inferiority, equivalence or superiority). Please advise.
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Immunoglobulins, normal human, for intravascular Yura 2016-01-13 06:51
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Immunoglobulins, normal human, for intravascular BE-proff 2016-01-14 11:15
- Immunoglobulins, normal human, for intravascularDr_Dan 2016-01-14 13:37
- Immunoglobulins, normal human, for intravascular Yura 2016-01-15 08:53
- Immunoglobulins, normal human, for intravascular Dr_Dan 2016-01-18 17:17
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