This document is an investigator's brochure that provides information about an investigational drug to clinical investigators. It includes sections on the purpose of the brochure, general considerations about its contents, nonclinical study data, effects seen in humans so far, and a summary and guidance for investigators. The purpose is to give investigators information on dosage, administration, safety monitoring and the rationale for further clinical research on the investigational drug.

1. Investigator’s Brochure
Presented by: Nitin Kale
M. Pharm 1st Year
Pharmacology
Rajarshi Shahu College
of Pharmacy, Buldana

2. Contents
Introduction
Purpose of investigator’s brochure(IB)
General consideration
Content of investigator’s brochure
 Appendices
 References
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3. Introduction:
• The Investigator’s brochure (IB) is a compilation of the
clinical and nonclinical data on the investigational products
that are relevant to the study of the products in human
subjects.
• The information should be presented in short, simple,
objective, and non-promotional from that enables a clinical or
potential investigator to understand it.
• It is prepared by sponsor.
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4. Purpose of IB:
• To Provide the information to investigators and others
involved in the trial with information such as the dose, dose
frequency/interval, methods of administration and safety
monitoring procedures.
• For assessment of appropriate proposed clinical trial a
medically qualified person should be participate in editing of
IB.
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5. General Considerations:
The IB should include
(1) Title Page
This should provide the
 Sponsor’s name:
Product:
Research Number:
Name(s): Chemical, Generic (if approved) &Trade Name(s).
Edition Number:
Release Date:
Replaces Previous Edition Number:
Date:
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6. 2) Confidentiality Statement:
The sponsor may wish to include a statement instructing the
investigator/recipients to treat the IB as a confidential
document for the sole information and use of the investigator’s
team and the IRB/IEC
 Contents of the Investigator’s Brochure:
The IB should contain the following sections
 Table of Contents:
 Summary:
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7.  Introduction:
Contains the chemical name (generic and trade name
when approved), all APIs, pharmacological class, the rationale
for performing research of the investigational products, and the
anticipated prophylactic, therapeutic, or diagnostic
indication(s).
 Physical, Chemical, and Pharmaceutical Properties and
Formulation:
Chemical and Structural Formula. Description of the
formulations. Instruction for storage and handling of the
dosage form.
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8.  Nonclinical Studies:
The information provided may include the following
 Species tested:
 Number and sex of animals in each group:
 Unit dose e.g. (mg/kg):
 Dose interval:
Route of administrations:
 Duration of dosing:
 Information on systemic distribution:
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9. (a) Nonclinical Pharmacology:
Efficacy models, receptor binding, and specificity other than the
intended therapeutic effect.
(b) Pharmacokinetics and Product Metabolism in Animals:
Absorption and the local and systemic bioavailability of the
investigational product and its metabolites, and their relationship to the
pharmacological and toxicological effect in animal species.
(c) Toxicology:
Described under the following headings where appropriate
- Single dose
- Repeated dose
- Carcinogenicity
- Special studies (e.g. irritancy and sensitization)
- Reproductive toxicity
- Genotoxicity ( mutagenicity )
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10. Effects in human:
(a)Pharmacokinetics & Product metabolism in humans:
 Pharmacokinetics
 Bioavailability
 population subgroups( e.g. Gender, age, and impaired organ
function).
 Interactions (e.g,product-product interactions and effects of
food).
(b) Safety & Efficacy:
safety, pharmacodynamics, efficacy and dose response that
were obtained from preceding trials in humans.
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11. Summary of Data & Guidance for the
investigator:
It provide and overall discussion of the nonclinical and
clinical data.
The published reports on related products should be
discussed. This could help the investigator to anticipate
adverse drug reactions or other problems in clinical trials.
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12. References on:
1. Publication
2. Reports
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14. References:
Integrated Addendum to ICH E6: Guideline for
Good Clinical Practice.
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