Bioequivalence and Bioavailability Forum

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

posted by Darborn – Taiwan, 2024-10-08 02:58 (273 d 11:29 ago) – Posting: # 24223
Views: 2,117

Thanks BEQool for the reply,

I totally agree with your point that a separate paragraph will be needed if it truly means that all high-risk products should be conducting those studies. However, this still needs to be clarified by the authorities.

Best regard

Complete thread:

• "Dose or Strength to be Studied" in ICH M13A Darborn 2024-09-30 01:14 [Regulatives / Guidelines] 
  • "Dose or Strength to be Studied" in ICH M13A BEQool 2024-10-07 10:33
    • "Dose or Strength to be Studied" in ICH M13ADarborn 2024-10-08 00:58