Investigator's Brochure - The Road Map for Investigators

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 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 1

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 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 2

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.   2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 3

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. 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 4

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: 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 5

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. 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 6

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. 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 7

8. Nonclinical studies The information provided may include the following 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 8 Species tested Number and sex of animals in each group Unit dose [e.g., milligram/kilogram(mg/kg) Dose interval Route of administration Duration of dosing Information on systematic distribution 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) 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 9

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. 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 10

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   2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 11

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   2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 12

13. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 13