Investigator's brochure

NON CLINICAL DRUG DEVELOPMENT

1. INVESTIGATOR’S BROCHURE Presented By- ROHIT R.K.S.D college of pharmacy, Kaithal ( Hry ) M.Pharma 1 st year (Pharmaceutics)

2. The Investigator's Brochure (IB) is a 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. 5/13/2016 2

3. Its purpose is to provide Information to the Investigators and others involved in the trial such as the dose, dose freque n c y /int e rval, m e th o ds of administration: and safety monitoring procedure. The IB also provides insight to support the clinical management of the study subjects during the course of the clinical trial. 5/13/2016 3

4. 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. 5/13/2016 4

5. Title Page Sponsor name The identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name(s) where legally permissible and desired by the sponsor). The release date. Confidential statement 5/13/2016 5

6. Confidentiality Statement The s p o nsor m a y wish to in c l u d e a 5/13/2016 6 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. The investigator brochure should include: 1.Table of Contents 2.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 available that is relevant to the stage of clinical development of the investigational product(IP). 5/13/2016 7

8. 3.Introduction Contains the chemical name (and generic and trade name(s) when approved) of the IP, all active ingredients , the IP(s) pharmacological class and its expected position within this class (e.g., advantages), the rationale for performing research with the IP(s), and the anticipated prophylactic, therapeutic, or diagnostic indication(s). General approach to be followed in evaluating the IP. 5/13/2016 8

9. 4.Description of IP 5/13/2016 9 re l evant p h ysical, chemica l , A brief summary should be given of the and pharmaceutical properties. A description of the formulation(s) to be used, including excipient, should be provided and justified if clinically relevant. Instructions for the storage and handling of the dosage form(s) should also be given.

10. 5.Nonclinical Studies 5/13/2016 10 The results of all relevant n onc l i ni c al toxi c ol o g y , pharmacology, pharmacokinetic, and investigational produ c t m e ta b ol i sm stu d ies sho u ld be provided in summary form.

11. The information provided may include 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 systemic distribution; 5/13/2016 11

12. Duration of post-exposure follow-up; 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. 5/13/2016 12

13. 5.1 Nonclinical Pharmacology A summary of the pharmacological aspects of the investigational product and, where appropriate, its significant metabolites studied in animals should be included. 5/13/2016 13

14. 5.2 Pharmacokinetics and Product Metabolism in Animals A summary of the pharmacokinetics and biological transformation and disposition (getting a drug into its appropriate position in the body and in an 5/13/2016 14 ap p ropr i ate c o nce nt r a t i o n) o f t h e investigational product in all species studied should be given.

15. 5.3 Toxicology (The study of the adverse effects of chemicals on animals) A summary of the toxicological effects found in relevant studies conducted in different animal species should be described under the following headings where appropriate: 5/13/2016 15

16. Single dose; Repeated dose; Carcinogenicity; Special studies (e.g., irritancy and sensitization); Reproductive toxicity; Genotoxicity (mutagenicity). 5/13/2016 16

17. 6. Effects in Humans A thorough discussion of the known effects of the investigational product(s) in humans should be provided, including information on pharmacokinetics, me t abol i sm, pharmacodynamics, dose response, safet y , efficac y , and o t her pharmacological activities. Where possible, a summary of each completed clinical trial should be provided. 5/13/2016 17

18. 6.1 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: 5/13/2016 18 Pharmacokinet i cs (includ i ng m e tabolism, as appropriate, and absorption, plas m a protein binding, distribution, and elimination). Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form.

19. Population subgroups (e.g., gender, age, and impaired organ function). Interactions (e.g., product-product interactions and effects of food). Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s)). 5/13/2016 19

20. 6.2 Safety and Efficacy 5/13/2016 20 A summ a ry o f in f orm a ti o n sho u ld be provided pro d uc t 's abou t the in v esti g at i o n al (incl u di n g me t ab o li t es, w h er e appropriate) safety , pharmacodynamics, efficacy, and dose response that were obtained from preceding trials in humans (healthy volunteers and/or patients).

21. 6.3 Marketing Experience The IB should identify countries where the investigational product has been marketed or approved. The IB should also identify all the countries where the investigational product did not receive approval/registration for marketing o r was wit h dr a wn fr o m marketing/registration. 5/13/2016 21

22. 7. Summary of Data and Guidance for the Investigator This section should provide an overall discussion of the nonclinical and clinical data of IP. IB provide the investigator a clear understanding of The possible risk Adverse reaction Observation & precaution needed for the clinical trial. 5/13/2016 22

23. Guid a nce fo r I n d u st r y E 6 Go o d Cli n ical Practice: Consolidated Guidance by ICH . 5/13/2016 23

24. 5/13/2016 24