Investigator’s Brochure (IB)
Introduction
The Investigator's Brochure (IB), which is kept up to date by a drug developer or investigator, is a thorough compilation of clinical and nonclinical data on the investigational product (drug, supplement, device, or other product) that contains the body of knowledge about the investigational product amassed prior to and throughout a drug trial. As new information becomes available, it is added to the IB, a document that is crucial to the drug development process.
The IB's goal is to combine data collected during preclinical and other clinical trials that are pertinent to studies of the investigational product in humans in order to give the investigator the knowledge they need to manage study subjects and conduct them throughout a clinical trial.
Whether a pharmaceutical product, gadget, or therapy intervention is the focus of the inquiry will affect the precise content of an investigational brochure. The words should be correctly modified and followed when referring to a device or therapy intervention.
A clinician or potential investigator should be able to understand the material and determine whether the proposed trial is acceptable on the basis of risk and reward on their own. The information should be presented in a clear, straightforward, objective, balanced, and non-promotional manner.
A thorough IB may not be required if the investigational substance is marketed and its pharmacology is well known among medical professionals. A basic product information brochure, package leaflet, or labelling may be a suitable substitute when allowed by regulatory authorities, provided that it contains up-to-date, thorough, and detailed information on all aspects of the investigational product that might be significant to the investigator. An IB tailored to the new use should be created if a marketed product is being investigated for a new use (i.e., new indication).
The Investigator Brochure should provide the following information:
Title Page
This information should include the name of the sponsor, the name of each investigational product (with the research number, chemical name, approved generic name, and trade name, if allowed by law and desired by the sponsor), and the date of release (of the I.B.). Additionally, it is advised that a reference be made to the edition number, as well as the number and date of the edition it replaces.
Confidentiality Statement
The IB should be treated as a confidential document for the use and knowledge of the investigator's team and the HREC, according to a statement the sponsor.
Contents of the Investigator’s Brochure
The IB should contain the following sections, each with literature references where appropriate:
Table of Contents
Summary
The important physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information that is available and relevant to the stage of clinical development of the investigational product or device should be highlighted in a clear description (ideally not exceeding two pages).
Introduction
The investigational product's chemical name, as well as its generic and trade names, should be included in a concise introduction statement .
All active components, the pharmacological class of the investigational product, and its anticipated placement within this class (e.g. advantages).
The justification for using the investigational product in research and any anticipated preventive, therapeutic, or diagnostic uses .
The opening paragraph should outline the broad strategy that will be used to assess the investigational product or device.
Physical, Chemical, and Pharmaceutical Properties and Formulation
The experimental product substance should be described, together with their chemical and/or structural formula, and any relevant physical, chemical, and pharmaceutical qualities should be briefly summarised.
A description of the formulation to be used, including excipients, should be provided and justified, if clinically relevant, to enable adequate safety measures to be taken throughout the study. Additionally, directions for using and handling the dosage form should be provided.
Non-Clinical Studies
Introduction
The results of all relevant non-clinical pharmacology, toxicology, pharmacokinetic, and investigational product metabolism studies should be provided in summary form.
This summary should address:
the methodological approach taken; the outcomes and a description of how the results apply to the therapy under investigation; and the potential adverse and unexpected effects in humans.
The information provided may include the following, as appropriate, if known/available:
a. species tested
b. number and sex of animals in each group
c. unit dose (e.g., milligram/kilogram (mg/kg))
d. dose interval
e. route of administration
f. duration of dosing
g. information on systemic distribution
h. duration of post-exposure follow-up
i. results, including the following aspects
j. nature and frequency of pharmacological or toxic effects
k. severity or intensity of pharmacological or toxic effects
l. time to onset of effects
m. reversibility of effects
n. duration of effects
o. dose response
Non-clinical Pharmacology
Included should be a synopsis of the experimental product's pharmacological properties and, where applicable, any important metabolites that have been examined in animal studies.
Pharmacokinetics and Product Metabolism in Animals
A summary of the pharmacokinetics and biological transformation and disposition of the investigational product in all species studied should be given.
Toxicology
A summary of the toxicological effects found in relevant studies conducted in different animal species should be described under the following headings where appropriate: Single dose, Repeated dose, Carcinogenicity, Special studies (e.g. irritancy and sensitization) , Reproductive toxicity, Genotoxicity (mutagenicity).
Effects in Humans
Pharmacokinetics and Product Metabolism in Humans
A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the following, if available: a. Pharmacokinetics (including metabolism, as appropriate, and absorption;
b. Plasma protein binding, distribution, and elimination);
c. Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form.
Safety and Efficacy
A summary of information should be provided about the investigational product's / products' (including metabolites, where appropriate) safety, pharmacodynamics, efficacy, and dose-response that were obtained from preceding trials in humans (healthy volunteers and/or patients).
Marketing Experience
The IB should identify countries where the investigational product has been marketed or approved. Any significant information arising from the marketed use should be summarised.
Summary of Data and Guidance for the Investigator
This section should provide a brief summary of the fundamental requirements or information available for a particular investigational product in order to allow a quick reference for the investigator. Summaries included in this section should not replace the information to be contained in the main body of the document.
References
Student Name: Anisetti Sai Manikanta
Student ID: CSRPL_STD_IND_HYD_ONL/CLS_005/012023
Qualification: Pharm. D
e-Mail ID: manikanta.anisetti8@gmail.com
Comments