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

posted by Darborn – Taiwan, 2024-10-08 02:58 (618 d 13:46 ago) – Posting: # 24223
Views: 3,820

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. :yes:

Best regard

Complete thread:

"Dose or Strength to be Studied" in ICH M13A Darborn 2024-09-30 01:14
- "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

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