Investigational new drug (IND)
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1. An Investigational New Drug (IND) application is required for testing an experimental drug in humans and must be submitted to regulatory agencies like the FDA for approval. 2. The IND application contains preclinical research data on animal and microbiological studies as well as clinical trial protocols, manufacturing information, and investigator details. 3. There are different types of INDs including commercial, non-commercial, emergency use, and treatment INDs which have varying requirements and purposes in the drug development process.
Investigational new drug (IND)
- 1. Investigational New Drug (IND) Presented by- Manish Kumar Singh (M.Pharm I Year) Presented to- Ms. Alka Assistant Professor Faculty of Pharmacy, BBDNIIT Lucknow
- 2. Drug Development : Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes pre-clinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.
- 4. Agencies for Drug Approval : The following table indicates about the group of agencies working for drug approval procedure in their respected countries.
- 5. Preclinical Studies : Computer stimulation, experimental animal studies, or in- vitro studies are performed to- 1. Identify a promising drug 2. Test for promising biological effect 3. Test for adverse effect A drug company may test many related compounds to identify 1 or 2 to take further in development. The FDA is not involved in this aspect of drug development but will review the study results for any compounds that are planned for clinical (human) testing.
- 6. Introduction : Investigational New Drug (IND) – It is the formal process by which a sponsor requests approval for testing a drug in humans- includes information developed during preclinical testing regarding safety and effectiveness. Includes an “investigator brochure” that ensure that clinicians conducting the trial and their institutional review boards (IRBs) are adequately informed about possible effects of the drug. Once IND application is submitted, the sponsor must wait for 30 days before initiating any clinical trials.
- 7. There are two IND categories : • Commercial INDs – These are applications that are submitted primarily by the companies to obtain marketing approval for a new product. • Non-Commercial INDs – These INDs are filed for noncommercial research. Types of IND : • Investigator INDs - This is submitted by a physician who both initiate and conducts an investigation and under whose immediate direction the investigational drug is administered or dispensed. • Commercial INDs – They are application that are submitted by companies whose ultimate goal is to obtain marketing approval for a new product. • Emergency use INDs - This IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR Sec.312.23 or Sec.312.34. • Treatment INDs - Other name is expanded access IND , this IND may be submitted for experimental drugs showing promise in clinical testing of serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place (21CFR312.34).
- 8. The IND application must contain information in three broad areas Animal pharmacology and toxicology studies. Manufacturing information. Clinical protocols and investigator information.
- 9. Guidance documents to help prepare INDs include : Guidance for industry : cGMP for phase 1 investigational drug. Guidance for industry : Exploratory IND studies. Content and format of INDs for phase 1 studies of drug including well characterized, therapeutic, biotechnology-derived products. Q & A - Content and format of INDs for phase 1 studies of drug including well characterized, therapeutic, biotechnology-derived products. Bioavailability and Bioequivalence studies for Orally Administered Drug Products – General considerations. This guidance should be useful for applicant planning to conduct BA and BE studies. IND exemption for studies of lawfully marketed drugs or biological for the treatment of cancer. Drug Master File (DMF) : A DMF is submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging and storing 1 or more human drugs. Immunotoxicology evaluation of investigational new drug : This guidance make recommendations to sponsors of INDs on the parameters that should be routinely assessed in toxicology studies to determine effects of a drug on immune function.
- 10. Law, Regulations, Policies and Procedures : Code of Federal Regulations (CFR) • Investigational New Drug Application21CFR Part 312 • INDA and NDAApplications for FDA approval to market a new drug.21CFR Part 314 • Orphan drugs.21CFR Part 316 • Good lab practice for non clinical laboratory studies21CFR Part 58 • Protection of human subjects.21CFR Part 50 • Institutional Review Board.21CFR Part 56 • Drug Labeling21CFR Part 201 • Financial Disclosure by Clinical Investigators.21CFR Part 54
- 11. Content of an IND : Cover sheet (form FDA 1571) Table of contents. Introductory statement and general investigational plan. Investigator’s brochure. Protocols. Chemistry, manufacturing and control information. Previous human experience with the investigational drug. Additional information.
- 12. Exemptions : Clinical studies conducted with marketed drugs are exempted from IND regulations provided that the investigation are conducted in compliance with the institutional review (21CFR 56) & informed consent (21CFR 50) requirements and the regulation prohibiting the promotion or sale of investigational drugs.
- 13. Withdrawal of an IND : AT any time sponsor can withdraw an effective IND. In such a case, FDA & IRB shall be so notified with reason for withdrawal, all clinical studies ended, all current investigators and subject notified, all stocks of drug returned to the sponsor or otherwise disposed off an request of sponsor in accordance with 312.59.
- 15. References : https://www.google.co.in/search?q=drug+development+proces s+images&rlz=1C1CHBF_enIN815IN815&oq=drug+develop ment+process+images&aqs=chrome..69i57.18166j0j8&source id=chrome&ie=UTF-8 Mulaje et al (2013). Procedure For Drug Approval in Different Countries : A Review. Journal of Drug Delivery & Therapeutics; 2013, 3(2), 233-238 Kaur J., (2014). US FDA Drug Approval Strategies for Pharmaceutical Industry. International Journal of Pharmaceutical Science Review and Research, 25(1),Mar-Apr 2014; Article no. 24, Page no. 137-146.