Investigator's brochure

What is Investigator's Brochure? What are its importance? why it is useful? What are the contents of Investigator's Brochure?

1. Investigator’s Brochure(IB) Guided By: Rituraj Bharadwaj Department of Pharmacy, ADTU Presented By: Atul Adhikari M.Pharm , 1 st sem Assam Downtown University, Guwahati

2. Compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. What is IB? 2 Department of Pharmacy, ADTU

3. It acts as a source of Information to the investigators and others involved in clinical trials(in simple and concise manner). It enables physicians and potential investigators to understand it and make his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial. What is the need of IB? 3 Department of Pharmacy, ADTU

4. Title Page: Sponsor’s name Identity of each investigational product ( research number, chemical or approved generic name & trade name(s) where legally permissible & desired by the sponsor) The release date Confidentiality statement : sponsor may wish to include a statement instructing investigators to treat the IB as a confidential document for the sole information and use of the investigator’s team and the IRB/IEC. What are the contents of IB? 4 Department of Pharmacy, ADTU

5. Table of contents Summary: not exceeding 2 pages highlighting significant physical, chemical/pharmaceutical/pharmacological/toxicological, p/k, metabolic and clinical information available for IP. Introduction: clinical bame , API, Cological class, anticipated therapeutic/diagnostic indications. Description of IP: Physical and chemical and pharmaceutrical properties of IP. storage and handling of IP Any structural similarity with other known compd given. 5 Department of Pharmacy, ADTU

6. 6. Non clinical studies: results of nonclinical pharmacological, toxicological, p/k, and investigational product metabolism studies should be provided in summary form. Information provided may include - species tested -no of sex in each group -Unit dose -Dose interval -Route of administration -Duration of dosing 6 Department of Pharmacy, ADTU

7. Nonclinical pharmacology: summary of pharmacological aspects of the IP studied in animals should be included. P/K and product metabolism in animals: summary of ADME and biological biotransformation and diposition . Toxicology: study of A/E on animals summary of toxicological effects found in animals species in single dose, repeated dose, carcinogenicity, special studies(irritancy, sensitization), reproductive toxicology, genotoxicity . 7 Department of Pharmacy, ADTU

8. 7. Effects in human: A throughout discussion of known effects of IP in humans to be provided. Information about p/k, metabolism, p/d, dose response, safety, efficacy and other pharmacological activities. p/k and product metabolism in human Safety and efficacy Marketing experience 8 Department of Pharmacy, ADTU

9. 8. Summary of data and guidance for the investigator: This section should contain clinical and nonclinical data of IP. IB provide the investigators a clear understading of: Possible risks A/E Observations and precautions needed for the clinical trial. 9 Department of Pharmacy, ADTU

10. http://www.fda.gov>drugs>ucm073122 Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance by ICH References 10 Department of Pharmacy, ADTU