INVESTIGATOR BROCHURE OF REGULATORY AFFAIRS

**Investigator's Brochure (IB) - Comprehensive Description**

### Introduction
The Investigator’s Brochure (IB) is a key document in clinical research that provides a comprehensive summary of the clinical and non-clinical data relevant to an investigational product. It is designed to inform investigators, regulators, and ethics committees about the potential risks and benefits of a drug under investigation. The IB is a regulatory requirement and plays a critical role in ensuring the safety of trial participants while guiding clinical trial conduct.

### Purpose of the Investigator's Brochure
The primary objective of the IB is to provide investigators and clinical trial personnel with adequate information about the investigational product to facilitate informed decision-making. The IB contains details such as dosage, frequency, administration methods, and safety monitoring procedures. It allows investigators to assess the risk-benefit ratio and ensures compliance with Good Clinical Practice (GCP) guidelines.

### General Considerations for the IB
The IB should be written clearly and concisely to facilitate comprehension by clinical investigators. It typically includes a title page, confidentiality statement, and various sections detailing the investigational product. A medically qualified individual should contribute to the preparation and editing of the IB to ensure accuracy and relevance.

### Content of the Investigator's Brochure
The IB is structured into several key sections, including:
1. **Title Page**
- Sponsor’s name
- Research product number
- Names (chemical, generic, trade names if applicable)
- Edition number and release date

2. **Confidentiality Statement**
- This section outlines confidentiality requirements to ensure that the document is only used by authorized personnel involved in the trial.

3. **Summary**
- A concise overview (preferably within two pages) summarizing the key findings from non-clinical and clinical studies, including pharmacological, toxicological, pharmacokinetic, and metabolic data.

4. **Introduction**
- Provides the rationale for the research, including the pharmacological class, chemical composition, and expected therapeutic indications of the investigational product.

5. **Physical, Chemical, and Pharmaceutical Properties and Formulation**
- Describes the structural formula, physicochemical characteristics, and formulation details, including excipients, storage conditions, and handling procedures.

6. **Non-Clinical Studies**
- **Species Tested:** The document details the species used in preclinical testing, sample sizes, and dosing regimens.
- **Pharmacological Studies:** Includes efficacy models, receptor binding assays, and specificity studies.
- **Pharmacokinetics:** Discusses absorption, distribution, metabolism, and elimination in animal models.
- **Toxicology Studies:** Provides information on single-dose, repeated-dose, reproductive toxicity, carcinogenicity, ge

1. INVESTIGATOR BROCHURE(IB) PRESENTED BY Laxmi math M pharma 1 st sem Department of pharmaceutics GUIDED BY Dr. R.G .PATIL BLDEAS’s SSM COLLEGE OF PHARMACY VIJAYAPURA

2. CONTENTS Introduction Purpose of Investigator's Brochure (IB) General consideration Content of Investigator's Brochure (IB)- References

3. INVESTIGATOR BROCHURE Definition: The IB is a comprehensive document that compiles all known clinical and non-clinical data relevant to the study of an investigational product.  The Investigator's Brochure (IB) is a crucial document in non-clinical drug development, summarizing all available clinical and non-clinical data on an investigational product, intended to inform investigators about potential risks and benefits, and is a regulatory requirement for clinical trials.  Who prepares it? The sponsor of the clinical trial (usually a pharmaceutical company) prepares the IB. 

4. Content: The IB includes information on:The investigational product itself (drug substance, formulation, etc.)  Non-clinical studies (pharmacological, toxicological, pharmacokinetic, etc.)  Clinical studies (safety and effectiveness in humans)  Summary of data and guidance for the investigator  Regulatory Importance: The IB is a regulatory requirement for clinical trials and is submitted to regulatory authorities (e.g., FDA in the US) along with the Clinical Trial Application (CTA).  ICH E6 Guideline: The International Council for Harmonisation (ICH) E6 guideline specifies that an IB should include information on the investigational product itself as well as on its use in non-clinical and clinical studies, together with a section providing guidance for the investigator on the use of the drug. 

5. PURPOSE •Its purpose is to provide Information to the Investigators and others involved in the trial such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedure. •The IB also provides insight to support the clinical management of the study subject during the course of the clinical trial. •The information should be presented in a concise and simple manner. •IB enables a clinician or potential investigator, to understand it and make his/her own unbiased risk benefit assessment of the appropriateness of the proposed trial. For this reason, a medically qualified person should generally participate in the editing of an IB.

6. 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: 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 .

7. CONTENTS OF THE INVESTIGATOR'S BROCHURE The IB should contain the following sections Confidentiality Statement (optional) Signature Page (optional) The investigator brochure should include: Table of Contents Summary Introduction Description of IB Nonclinical Studie Effects in Humans 7. Summary of Data and Guidance for the Investigator.

8. 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. 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 A description including the chemical and structural formula, relevant physical, chemical, and pharmaceutical properties. description of the formulations, including excipients, Instructions for the storage and handling of the dosage form.

9. Nonclinical Studies: The information provided may include the following Species tested. Number and sex of animals in each group. Unit dose (e.g., milligram/ kilograin (mg/kg)). Dose interval. Route of administration. Duration of dosing. Information on systemic distribution. Duration of post-exposure follow-up.

10. Results, including the following aspects:- Nature and frequency of pharmacological or toxic effects Severity or intensity of pharmacological or toxic effects Time to onset of effects Reversibility of effects- Duration of effects Dose response(a) Nonclinical Pharmacology: Efficacy models, receptor binding, and specificity other than the intended therapeutic effect.

11. (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. irritańcy and sensitisation ) Reproductive toxicity Genotoxicity (mutagenicity)

12. Effects in Humans (a) Pharmacokinetics and Product Metabolism in Humans:- Pharmacokinetics (including metabolism, absorption, plasma protein binding, distribution, and elimination). Bioavailability. Population subgroups (e.g., gender, age, and impaired organ function). 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 trials in humans.(healthy volunteers and/or patient) Summary of Data and Guidance for the Investigator: provide an 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. References on Publications 2. Reports

13. REFERENCES: Guidance for industry E6 Good Clinical Practice: Consolidated Guidance by ICH. Handbook for Clinical trial by European Union. http:/www.europeanmedicalagency.com https://www.slideshare.net/slideshow/non-clinical-drug-development-ppt/142811392 https://www.slideshare.net/slideshow/investigators-brochure-ib/124287737 .