Indstudies
- 1. IND enabling studies Presented By : Dolly Chauhan M.Pharm (Pharmacology) 2nd Semester
- 2. ļ¶ An IND is a submission to the food and drug administration (FDA) requesting permission to initiate a clinical study of a new drug product. ļ¶ The Federal Food ,Drug and Cosmetic act requires that drugs have an approved marketing application before they can be shipped in interstate commerce
- 3. ļ¶The IND application allows a company to initiate and conduct clinical studies for their new drug products. ļ¶The IND application provides the FDA with the data necessary to decide whether the new drug and the proposed clinical trial pose a reasonable risk to the human subjects participating in the study.
- 4. ļ§ FDA's role in the development of a new drug begins when the drug's sponsor has screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans ļ§ The molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and ļ½ becomes a new drug subject to specific requirements of the drug regulatory system ļ§ Drug is to be the subjected to an approved marketing application before it is transported or distributed across state lines ļ§ IND- notice of claimed investigational exemption for a new drug must be filed with regulatory body.
- 5. ļ Submission application to FDA requesting permission to initiate the study of Newdrug product. ļ Pharmaceutical company obtains permission to clinical trial before a marketing application for the drug has been approved
- 6. ļ FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk ļ Product is reasonably safe for initial use in humans ļ If the compound exhibits pharmacological activity that justifies commercial development
- 7. Pharmaceuticals may move across state lines during two stages of human use ā¢ Research prior to āapprovalā ā Requires research permit: e.g., Investigational New Drug Exemption (IND) ā¢ Marketing after āapprovalā ā Requires marketing permit: e.g., New Drug Application (NDA)
- 8. Applicant (Drug Sponsor): ļ who assumes responsibility for the marketing of a new drug ļ IND application provides FDA with data necessary to decide : New drug proposed Clinical trial pose a reasonable risk to human subjects participating in the study
- 9. The IND application allows the company to initiate & conduct the clinical studies of their new drug Product. ā¢ The safety of the Clinical trial Subjects is always the primary concern of FDA.
- 10. Primary goal of the Sponsor should be to demonstrate to the FDA that the - new drug - proposed trial - entire clinical development plan described in the IND is designed to minimize the risk to the trial subjects.
- 11. New chemical entity not approved for the indication Being administered at the new dosage level combination with anther drug All clinical studies where the new drug is administered to human subjects
- 12. Non clinical studies Approved drug and the study is within its approved indication for use
- 13. COMMERCIAL IND : goal is to obtain marketing approval for a new product. NON-COMMERCIAL IND : It includes ļ INVESTIGATOR IND : In this case ,the physician is both the sponsor and investigator
- 14. Investigator IND o Submitted by a physician who both initiates and conducts an investigation, and under ļ½ whose immediate direction the investigational drug is administered or dispensed. o Physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population Emergency Use IND o Allows FDA to authorize use of an experimental drug in an emergency situation o Does not allow time for submission of an IND in accordance with 21CFR , PART 312 (INDA) Treatment IND o Submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place
- 15. ļ EMERGENCY IND : FDA authorize immediate dispensing of a non-approved drug in a life threatening situation when no standard acceptable therapy is available. TREATMENT IND : FDA will permit investigational drug to be used to treat a serious or life threatening disease or if there is no comparable alternative drug available.
- 18. 312.20 REQUIREMENTS OF AN IND ā¢ A sponsor shall submit an IND to FDA who intends to conduct a clinical investigation. ā¢ Investigation is not supposed to begin without prior written authorization of FDA
- 19. ā¢ Phase 1 - ADME (20- 80) healthy subjects ā¢ Phase 2 ā effectiveness in particular indication (several hundred patients) ā¢ Phase 3 ā safety and effectiveness ( 100- 1000) subjects.
- 20. To assure safety and rights of the subject. ā¢ To assure the scientific quality of investigation will yield data capable of meeting statutory standards for marketing approval ā¢ Focus should be on general investigational plan & protocol which should be supported by additional information including animal toxicological studies
- 21. 1. Cover sheet (FORM FDA 1571) 2. Table of contents 3. Introductory statement and a general investigational plan 4. Investigators brochure 5. Protocols 6. Chemistry , manufacturing and control information 7. Pharmacology and Toxicology information 8.Previous human experience with the investigational drug 9.Other relevant information like no of IND submissions 10. Protocol amendments, any changes in the protocol
- 22. ļ§ Name of the sponsor ļ§ Date of submission ļ§ Address ļ§ Telephone number ļ§ Name(s) of Drug ļ§ IND Number ļ§ Indication ļ§ Phase of clinical investigation to be conducted list no.of all investigational new drug application ļ§ Serial no. ļ§ Contents of application
- 23. 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
- 24. Structural formula of drug Summary of pharmacological , toxicological , pharmacokinetic effects in animals Safety and efficacy Purpose of study Dose / dosefrequency Monitoring procedures
- 25. - It describes ā the objective of the study - the trial design - how subjects would be selected - how the trail is to be conducted.
- 26. Determines the adequacy of methods used to manufacture and assay investigational compound Safety concerns Describe drug substances Method of preparation ļ¶ Reagent and solvents ļ¶ Acceptable limits and analytical methods to ensure quality and purity of drug.
- 27. non-clinical safety data that sponsor generated to prove that the IPis safe for clinical study . the amount & type of data depends on class of new drug duration of proposed clinical trial, patient population that will be exposed during the trial
- 28. Pk studies Pd studies observed adverse event profile
- 29. 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.
- 30. The ātreatment useā of a drug includes the use of a drug for diagnostic purposes. If a protocol for an investigational drug meets the criteria of this section, the protocol is to be submitted as a treatment protocol
- 31. A treatment protocol is required to contain the following: ā¢ The intended use of the drug. ā¢ An explanation of the rationale for use of the drug, ā¢ A brief description of the criteria for patient selection, The method of administration of the drug and the dosages. ā¢ A description of clinical procedures, laboratory tests, or other measures.
- 32. Once the IND is stamped as received , it is sent to CDER for review. ā¢ It is further categorically divided into different sections ā ļ Medical ļ Chemistry ļ Pharmacology / Toxicology ļ Statistics
- 33. ļ Safety Review ļ Clinical Hold Decision ļ Notify Sponsor ļ Sponsor Notified of Deficiencies ļ Study Ongoing ā¢ Once CDER's 30-day initial review period expires, clinical studies can be initiated, unless a clinical hold has been placed.
- 34. 1.Helps in the result of successful preclinical development program. 2.IND is also the vehicle through which a sponsor advice the next stage of drug development i.e. clinical trial. 3.The preclinical study, helps the sponsorās primary goal to determine that the product is reasonably safe for initial use in human. 4.It is important in the development of compounds commercial if it exhibit pharmacological activity. 5.It is important in assuring the marketing of a new drug and responsibility for compliance of sponsor.
- 35. 6.It is important for the company to initiate and conduct the clinical studies of their new product. 7.It secure the safety and effectiveness of the clinical trial subjects. 8.IND can be alternative in a life threatening situation when no standard acceptable therapy is available. 9.It gives the indication of new drugs. 10.Pharmacology and toxicology information of new drugs.