INVESTIGATIONAL NEW DRUG APPLICATION.pptx

INVESTIGATIONAL NEW DRUG APPLICATION

1. Investigational new drug application Mohammed Sadhiq M S Ist M.pharm Dept.Of Pharmacy Practice

2. DEFINITION Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The IND is the means through which the sponsor technically obtains this exemption from the FDA. Current Federal law requires that a drug be the subject of an approved marketing applicationbefore it is transported or distributed across state lines. 20XX Pitch Deck 2

3. 20XX Pitch Deck 4 When INDA Required? INDA is required if any pharmaceutical company wants to conduct clinical trails of an unapproved drug. INDA would be required to conduct clinical trials if the drug is new chemical entity, not approved for indication under investigation new dosage form. In combination with another drug which is not approved All clinical studies where new drugs are administered to human subjects, regardless he whether the drug is commercially developed, require an IND.

4. TYPES OF IND INVESTIGATOR IND Submitted by physician who both initiates and conducts the study including the immediate supervision of the use of the study drug. EMERGENCY USE IND FDA allow to authorise the new experimental drug in an emergency situation That doesn't allow time for submission of IND TREATMENT IND Submitted for experimental drug showing promise inclinical testing for serious conditions. Final clinical work and review conducted by FDA 20XX Pitch Deck 5

5. Classification of ind Commercial 20XX Pitch Deck 6 Permits sponsor to collect data on clinical safety and effectiveness needed for application for marketing in the form of NDA Research (non-commercial) Permits the sponsor to use drug in research to obtain advanced scientific knowledge of new drug. No plan to market the product.

6. CONTENTS OF INDA Animal Pharmacology & Toxicology Studies Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans. Manufacturing Information Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed cure that the company can adequately produce and supply consistent batches of the drug. Clinical Protocols and Investigator Information Commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations. Pitch Deck 7

7. Format of inda 20XX Pitch Deck 8 A. Cover sheet (Form FDA-1571) Name, address, telephone of sponsor Identification of phases Commitment not to begin CT until IND approval Commitment by IRB-Form 56Commitment for conducting CT- accordance with regulations Name, title-Monitor Name, title-person(s) for reviewing Name, Address of CRO, if any Signature of sponsor B. Table of contents C. Introductory statement & general investigational plan D. Investigators brochure E. Study protocol F. Investigator facilities & IRB data G. Chemistry manufacturing & control data H. Pharmacology & toxicology data Previous human experience

8. RESOURCES FOR IND APPLICATION Pre-IND consultation program: offered by CDER(center for drug evaluation and research) Guidance documents for IND’S Laws, regulations, policies & procedures Code of federal regulations (CFR) Manual policies & procedures 20XX Pitch Deck 9

9. GUIDANCE DOCUMENTS FOR INDS 20XX Pitch Deck 10 Guidance documents represent the Agency's current thinking on a particular subject. These documents provide FDA review staff and applicants/sponsors with guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products. They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures.

10. 20XX Pitch Deck 11   Layout chart for IND Application

11. THANK YOU 20XX Pitch Deck 12