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Blank Investigator's Brochure Template584206520231203
Blank Investigator's Brochure Template584206520231203
Blank Investigator's Brochure Template584206520231203
Compound No.:
Investigator’s Brochure Version:
INVESTIGATOR’S BROCHURE
Investigational Product
Compound Number:
Chemical or Approved
Generic Name
The information contained in this document is the property of [Enter client name] and
may not be reproduced, published or disclosed to others without written authorisation
from [Enter client name].
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Sponsor Signatory:
Enter position
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TABLE OF CONTENTS
PAGE
ABBREVIATIONS................................................................................................6
1. SUMMARY....................................................................................................7
1.1. Physical, Chemical and Pharmaceutical Properties and Formulation7
1.2. Nonclinical Pharmacology.................................................................7
1.3. Nonclinical Pharmacokinetics...........................................................7
1.4. Toxicology.........................................................................................7
1.5. Metabolic Information........................................................................7
1.6. Clinical Experience............................................................................7
2. INTRODUCTION..........................................................................................8
2.1. Background.......................................................................................8
2.2. Rationale for [Enter Compound Number]..........................................8
2.3. References........................................................................................8
4. NONCLINICAL STUDIES...........................................................................10
4.1. Nonclinical Test Material.................................................................10
4.2. Nonclinical Pharmacology...............................................................10
4.2.1. Nonclinical Pharmacology Studies Performed.................10
4.2.2. Primary Pharmacodynamics............................................11
4.2.3. Secondary Pharmacodynamics.......................................11
4.2.4. Safety Pharmacology.......................................................11
4.2.4.1. Overt central and peripheral effects...............11
4.2.4.2. Effects on the cardiovascular system.............11
4.2.4.3. Effects on the respiratory system...................11
4.2.4.4. Effects on the kidney......................................11
4.2.5. References.......................................................................11
4.3. Pharmacokinetics and Product Metabolism in Animals..................12
4.3.1. Analytical Methods and Validation...................................12
4.3.2. Absorption and Pharmacokinetics...................................12
4.3.2.1. Single dose pharmacokinetic studies with
[Enter compound number]..............................12
4.3.2.2. Repeat dose toxicokinetic studies with [Enter
compound number]........................................13
4.3.3. Distribution.......................................................................13
4.3.3.1. In vitro studies................................................13
4.3.3.2. Whole-body autoradiography studies.............13
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5. EFFECTS IN HUMANS..............................................................................21
5.1. Introduction.....................................................................................22
5.2. Phase I Data...................................................................................22
5.2.1. Summary of Phase I Clinical Safety................................22
5.3. Phase II Data..................................................................................22
5.3.1. Overall Conclusions of Phase II Clinical Trial Safety and
Efficacy............................................................................22
5.3.1.1. Efficacy:..........................................................22
5.3.1.2. Safety:............................................................22
5.4. Phase III Data.................................................................................22
5.5. Marketing (Phase IV) Data..............................................................22
5.5.1. Regulatory Approval........................................................22
5.5.1.1. Regulatory approval granted..........................22
5.5.1.2. Regulatory approval rejected.........................22
5.5.2. Marketing.........................................................................23
5.5.2.1. Countries where the investigational product is
marketed........................................................23
5.5.2.2. Countries where the investigational product
has been withdrawn.......................................23
5.5.3. Additional Clinical Information.........................................23
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7. APPENDICES.............................................................................................26
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ABBREVIATIONS
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1. SUMMARY
This section should contain a brief (maximum of two pages) summary highlighting the
significant points included in this document. The following subheadings should be
addressed. If they are not applicable then state this.
1.4. Toxicology
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2. INTRODUCTION
2.1. Background
Briefly state the investigational product (IP) chemical name, generic name (if approved)
and trade name (if approved). List the active ingredients and confirm which
pharmacological class the IP is in. Briefly discuss its expected position within this class
(i.e., the advantages it is expected to have over other products in that class).
Briefly discuss the rationale for performing research with the IP. Provide information on
the general approach to be followed in developing/evaluating the IP.
2.3. References
Alternatively, if there are not a large number of references, a single reference section can
be place at the end of the document with the reference subsections being removed.
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Other Names:
Molecular Formula:
Molecular Weight:
Physical Form:
Provide instructions for the storage and handling of the IP in its dosage form.
3.5. References
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4. NONCLINICAL STUDIES
State what material was used in the nonclinical studies and what form that material took.
This section should include the results of all relevant nonclinical pharmacology studies.
Summarise the pharmacological aspects of the IP studied in animals and those of its
significant metabolites. Outline the methodology used and the study results and discuss
what relevance these findings have to the proposed therapeutic use in humans. Highlight
any possible unfavourable or unintended effects these results indicate might occur in
humans.
A range of in vitro and in vivo studies have been performed in order to characterise the
pharmacodynamics of [Enter compound number]. Table 1 presents a list of the
nonclinical pharmacology studies conducted to date.
- Reversibility of effects.
- Duration of effects.
- Dose response.
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If applicable compare and discuss the therapeutic index (i.e., the effective and nontoxic
dose findings) in the same animal species. The subheadings below may be helpful.
4.2.5. References
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Pharmacokinetic
Toxicokinetic
Distribution
Metabolism
Excretion
Succinctly describe the analytical methods used to measure the blood and tissue levels of
the IP. Outline the validation process relating to these methods.
Discuss the absorption and pharmacokinetic results of any single dose pharmacokinetic
studies.
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4.3.3. Distribution
Discuss the results of studies in all species that have investigated IP, and metabolite,
distribution. Review both local and systemic bioavailability. The following subheadings
may be helpful.
4.3.4. Metabolism
4.3.5. Excretion
Discuss the excretion of the IP and its metabolites in appropriate animal species (adjust
subheadings if required).
4.3.5.1. Rat
4.3.5.2. Dog
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4.3.7. References
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4.4. Toxicology
The toxicity of [Enter compound number] has been evaluated in single and repeat dose
oral studies of up to 12 months’ duration. The reproductive and genetic toxicity of [Enter
compound number] has also been investigated. A listing of these studies is presented in
Table 3.
Repeat Dose
Genotoxicity
Reproductive Toxicity
Local Tolerance
Other Toxicity
Key:
DRF = Dose range finding
M = male; F = female
NA = Not applicable
Discuss the results of these studies and include the following information:
- Reversibility of effects.
- Duration of effects.
- Dose response.
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Include information on single dose studies under the appropriate species heading.
4.4.1.1. Rat
4.4.1.2. Dog
Include information on repeat dose studies under the appropriate species heading.
4.4.2.1. Mouse
4.4.2.2. Rat
4.4.2.3. Dog
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4.4.6. Carcinogenicity
4.4.8. References
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The following section should only be completed if human studies have been performed.
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4.5.1. References
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5. EFFECTS IN HUMANS
This section should include a thorough discussion of the effects of the IP in humans. A
summary of each completed clinical trial should be provided as well as any additional
information obtained through alternative methods e.g., experience during marketing.
For first-time-in-human IBs this section can be deleted. Alternatively, if dose selection
for human studies is based on pharmacokinetic modelling, any relevant modelling data
can be presented in this section.
- Pharmacokinetics:
o Describe the possible risks and anticipated ADRs in future studies based
on the current experience with the IP.
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5.1. Introduction
5.3.1.1. Efficacy
1.
2.
5.3.1.2. Safety
1.
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2.
List those countries where regulatory approval has been granted or rejected.
List those countries where the IP is currently being marketed and has been withdrawn
from the market.
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Some events presented in the DCSI may have been identified from ongoing, blinded
clinical studies. If this is the case, these data may not be presented elsewhere in the
Investigator's Brochure, however they will be described more fully once the studies have
been completed and the final data have been unblinded and analysed.
This section should provide an overall discussion of the nonclinical and clinical data and
summarise the information from various sources on different aspects of the IP. If reports
on related products have been published then these may be discussed if appropriate (i.e.,
if it could help the investigator to anticipate ADRs relating to this drug class).
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6.3. Contraindications
6.5. Interactions
6.8. Overdose
6.11. References
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7. APPENDICES
Add appendices as appropriate.
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