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Dear all,
The guidelines say that single dose studies are the most sensitive at distinguishing formulation effects (section 4.1.1). However, we keep getting statements like this from authorities: A multiple dose study at the highest dose strength is considered to be most sensitive model for detecting differences.
Can someone explain why that would be so? And are there papers that discuss this?
Thanks.
The guidelines say that single dose studies are the most sensitive at distinguishing formulation effects (section 4.1.1). However, we keep getting statements like this from authorities: A multiple dose study at the highest dose strength is considered to be most sensitive model for detecting differences.
Can someone explain why that would be so? And are there papers that discuss this?
Thanks.
Complete thread:
- Most sensitiveThe Outlaw Torn 2011-11-02 12:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Steady state most sensitive: in some particular cases – yes Helmut 2011-11-02 15:31
- Steady state most sensitive: in some particular cases – yes The Outlaw Torn 2011-11-03 12:26
- Steady state most sensitive: in some particular cases – yes ElMaestro 2011-11-03 12:28
- Why, oh why? Helmut 2011-11-03 14:46
- Steady state most sensitive: in some particular cases – yes Helmut 2011-11-02 15:31
Ing. Helmut Schütz