In this detailed blog, you’ll learn about:
- What IB is and why it’s important
- Components of IB
Table of Contents
What is IB?
An Investigational Brochure (IB) is a document that provides essential information about an investigational drug to clinical trial investigators, regulatory authorities, and ethics committees.
Purpose of IB
The purpose of IB is to communicate the benefits and risks associated with the drug and to ensure that everyone involved in the clinical trial has the same understanding of the drug’s properties.
Significance of IB
Crucial to various processes that regulate clinical research into new drugs, the content of an Investigator’s Brochure is well defined. The ICH E6 guideline specifies that it should include information on the drug product to be investigated and its performance in non-clinical studies along with specific guidance to investigators on the drugs use.
As well as serving as the primary reference document for determining whether an adverse event is ‘unexpected’, the Investigator’s Brochure plays other roles:
- A regulatory prerequisite for clinical studies, as specified in the ICH E6 Guideline for Good Clinical Practice. (Click here to learn more in nuances about ICH guidelines in a different perspective.)
- Consideration by independent ethics committees
- A requirement for Investigational New Drug applications (USA)
- To support Investigational Medicinal Product Dossier and Pediatric Investigation Plan submissions in Europe
- To form the basis of other documents – briefing packages and summaries required for marketing authorisation
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Important Components of IB
The IB contains several important components, including:
Chemical and Physical Properties:
Information on the drug’s chemical and physical properties.
Mechanism of Action:
Description of the drug’s mechanism of action.
Pharmacokinetics and Pharmacodynamics:
Information on the drug’s pharmacokinetics and pharmacodynamics.
Safety Data:
Safety data from preclinical studies.
Proposed Clinical Trial:
Information on the proposed clinical trial, including the patient population to enroll and dosing regimens.
Potential Risks and Adverse Events:
Information on any potential risks or adverse events that may associated with the drug.
Conclusion
Considered a multidisciplinary document, the Investigator’s Brochure provides a summary of research work completed on an investigational medicinal product.
It serves several purposes and evolves as the development program progresses.
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FAQ:
What is Investigational Brochure (IB)?
Purpose of Investigational Brochure (IB)
What are the components of Investigational Brochure (IB)?
2. Mechanism of Action
3. Pharmacokinetics and Pharmacodynamics
4. Safety Data
5. Proposed Clinical Trial
6. Potential Risks and Adverse Events
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