1.

What Are The Modules In Ctd?

Answer»

The Common Technical Document is divided into five modules:

  1. Module 1 : Administrative information and PRESCRIBING information
  2. Module 2 :Common Technical Document summaries (Overview and summary of modules 3 to 5)
  3. Module 3 : Quality 
  4. Module 4 : Nonclinical Study REPORTS (toxicology studies)
  5. Module 5 : Clinical Study Reports (clinical studies)

The Common Technical Document is divided into five modules:


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