1.

What Is Ib?

Answer»

The Investigator's Brochure (IB) is a BASIC document which is required in a clinical trial According to the FDA regulations (Title 21 CFR 312.23), an Investigator's Brochure must contain:

  1. Description of the drug substance and the formulation
  2. Summary of the pharmacological and toxicological effects
  3. Summary of INFORMATION RELATING to its safety and effectiveness in humans
  4. Description of possible risks and ADVERSE REACTIONS to be anticipated, and the precautions or special monitoring that the investigator should take.

The Investigator's Brochure (IB) is a basic document which is required in a clinical trial According to the FDA regulations (Title 21 CFR 312.23), an Investigator's Brochure must contain:


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