IND enabling.pptx

IND enabling

1. Principle of IND The purpose of IND-enabling studies is  to secure approval to conduct the first-in-human clinical trials with a new drug . To assure the scientific quality of investigation will yield data capable of meeting statutory standards for marketing approval Focus should be on general investigational plan & protocol which should be supported by additional information including animal toxicological studies 1

2. IND Enabling Studies 2

3. IND Content & Format of an IND Application Cover sheet (FORM FDA 1571) Table of contents Introductory statement and a general investigational plan Investigators brochure Protocols Chemistry, manufacturing and control information Pharmacology and Toxicology information Previous human experience with the investigational drug Other relevant information like no of IND submissions Protocol amendments, any changes in the protocol 3

4. Cover sheet 4

5. General Investigational Plan Description of clinical studies planned for the experimental drug. Purpose of the study  Indication to be studied  Types of trials to be initiated  Number of study subjects  Risks involved 5

6. Investigators brochure (IB) Structural formula of drug Summary of pharmacological, toxicological, pharmacokinetic effects in animals Safety and efficacy Purpose of study Dose / dose frequency Monitoring procedures 6

7. Protocols  7

8. Chemistry, manufacturing and control information 8

9. Pharmacology and Toxicology information 9

10. Treatment use of an investigational new drug purpose of this section is to facilitate the availability of promising new drugs to desperately ill patients In the case of an immediately life-threatening disease, a drug may be made available for treatment use under this section earlier than Phase 3, but ordinarily not earlier than Phase 2. 10

11. FDA's IND Review Process 11

12. Importance of IND Helps in the result of successful preclinical development program. IND is also the vehicle through which a sponsor advice the next stage of drug development i.e. clinical trial. The preclinical study, helps the sponsor's primary goal to determine that the product is reasonably safe for initial use in human. It is important in the commercial development of compounds if it exhibit pharmacological activity. It is important in assuring the marketing of a new drug and responsibility for compliance of sponsor 12

13. THANK YOU 13