The Investigator's Brochure (IB) is a document that serves as a comprehensive reference manual for investigators who are conducting clinical trials. The IB typically contains information about the investigational product being studied, including its pharmacology, pharmacokinetics, safety and efficacy data, and other relevant information. The IB is designed to provide investigators with all the information they need to understand the product being studied and its potential risks and benefits. It also provides guidance on how to conduct the clinical trial, including the study design, dosing and administration, monitoring and assessment of safety and efficacy, and other important aspects of the trial.

1. Welcome
INVESTIGATOR’S BROCHURE
ARAVIND PASUPULA
B.PHARMACY
CSRPL_STD_IND_HYD_OFL/CLS_016/012023
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2. Index
• INTRODUCTION
• PURPOSE OF INVESTIGATOR’S BROCHURE
• GENERAL INFORMATION THAT SHOULD BE INCLUDED IN
INVESTIGATOR’S BROCHURE
• CONTENT OF INVESTIGATOR’S BROCHURE
• SUMMARY
• REFERENCES
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3. INTRODUCTION
 An Investigator’s Brochure is a collection of clinical and non-clinical data about
the investigational products that are the focus of the study. The brochure
should provide an ongoing insight into the clinical trial study participants
during the duration of the trial.
 IB is a comprehensive document summarizing the information about the
investigational product obtained during a clinical trail.
 The information should be presented in short, simple, objective, and non
promotional form that enables a clinical or potential investigator to
understand it.
 IB is prepared by sponsor and having up to date information about IMP.
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4. PURPOSE OF INVESTIGATOR’S
BROCHURE
 To provide the information to investigators and other involved in the trial such
as dose, dose frequency or interval methods of administration and safety
monitoring procedures.
 The IB also provides insight to support the study subjects, to clinical
management during the course of clinical trial.
 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
-Confidentiality statement[optional]
-Signature[optional]
TABLE OF CONTENTS:
Summary :
A brief summary [preferably not exceeding two pages] should be given
highlighting the significant physical, chemical, pharmaceutical, pharmacological,
toxicological pharmacokinetic, metabolic, and clinical information.
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7.  INTRODUCTION
Contains the chemical name[generic and trade name when approved]
all APIs, pharmacological cells, the rationale for preforming research of
the investigational products, and the anticipated prophylactic,
therapeutic, or diagnostic indication[s].
 Physical, Chemical, and Pharmaceutical Properties and
Formulation:
A description including the chemical and structural formula,
relevant physical, chemical, and pharmaceutical properties, description
of the formulation, including excipients instructions for the storage and
handling of the dosage form.
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8.  Nonclinical studies
The information provided may include the following
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o Species tested
o Number and sex of animals in each group
o Unit dose [e.g., milligram/kilogram(mg/kg)
o Dose interval
o Route of administration
o Duration of dosing
o Information on systematic distribution
o Duration of post-exposure follow-up

9. (a) Non-clinical Pharmacology
Efficacy models, receptor binding, and specificity other then the intended therapeutic
effect.
(b)Pharmacokinetics and Product metabolism in Animals :
Absorption and the local and systematic bioavailability of the investigational product
and its metabolites, and their relationship to the pharmacological and toxicological effects 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 ON HUMANS
(a)Pharmacokinetics and Product metabolism in Humans:
- Pharmacokinetics (including metabolism, absorption, plasma protein
binding,
distribution, and elimination)
- Bioavailability.
- Population subgroups.
- Interactions(e.g., product-product interactions and effects of food)
(b) Safety and Efficacy:
Safety, pharmacodynamics, efficacy, and dose response that were
obtained
from preceding trails in humans.(health volunteers and/or patient.
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11. Summary of data and guidance for the investigator:
• An overall discussion of the nonclinical and clinical data. They provide published
reports on related products that should be discussed . This could help the
investigator to anticipate adverse drug reactions or other problems in a clinical
trial
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12. References:
https://www.research.colostate.edu/ricro/qa/investigators-brochure/
https://ichgcp.net/7-investigators-brochure
https://www.slideshare.net/SachinFartade/investigators-brochure-ib
https://novotech-cro.com/faq/what-investigators-brochure
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13. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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