"Dose or Strength to be Studied" in ICH M13A [Regulatives / Guidelines]

posted by BEQool  – 2024-10-07 12:33 (257 d 07:17 ago) – Posting: # 24221
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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

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