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Register"Dose or Strength to be Studied" in ICH M13A [Regulatives / Guidelines]
Hello,
I was wondering the exact same thing but I think that this red text applies just to high-risk products with less than proportional increases in AUC and/or Cmax with increasing dose over the range of strengths proposed (the latter explanation of yours).
Otherwise this would have been written at least in a seperate paragraph as this whole paragraph is talking about less than proportional increases in AUC and/or Cmax with increasing dose.
Regards
BEQool
I was wondering the exact same thing but I think that this red text applies just to high-risk products with less than proportional increases in AUC and/or Cmax with increasing dose over the range of strengths proposed (the latter explanation of yours).
Otherwise this would have been written at least in a seperate paragraph as this whole paragraph is talking about less than proportional increases in AUC and/or Cmax with increasing dose.
Regards
BEQool
Complete thread:
- "Dose or Strength to be Studied" in ICH M13A Darborn 2024-09-30 01:14 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- "Dose or Strength to be Studied" in ICH M13ABEQool 2024-10-07 10:33
- "Dose or Strength to be Studied" in ICH M13A Darborn 2024-10-08 00:58
- "Dose or Strength to be Studied" in ICH M13ABEQool 2024-10-07 10:33
Ing. Helmut Schütz