"Dose or Strength to be Studied" in ICH M13A [Regulatives / Guidelines]
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
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
- "Dose or Strength to be Studied" in ICH M13A BEQool 2024-10-07 10:33