Investigational New Drugs; early phase in drug development in the US American approval procedure
Investigational New Drug IOM Institute of Medicine
Investigational New Drug] Permits granted by the Food and Drug Administration for the use of new drugs with patients on an experimental basis.
(Investigative New Drug) Application to the FDA requesting approval to begin human clinical trials
Investigational New Drug Application (USA) Formal means by which a company requests permission from the FDA to expose people to an experimental drug compound for clinical trials.
The FDA grants an Investigational New Drug for potential pharmaceutical products that qualify based upon Pre-Clinical Data submitted to the FDA for its approval. An IND is required prior to testing any potential drug in humans. NDA An NDA (New Drug Approval) is granted by the FDA for products that qualify for safety and efficacy during Clinical Testing in humans. An NDA is required to sell a prescription pharmaceutical product in the U.S.
Investigational New Drug. The name given to an experimental drug after the Drugs Directorate of Health and Welfare Canada has agreed that it can be tested in people.
Investigational New Drug. Refers to the Food and Drug Administrationâ€(tm)s (FDA) program by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND for safety to assure that research subjects will not be subjected to unreasonable risk. The application has three main sub-sections: Animal Pharmacology and Toxicology Studies; Manufacturing Information; and Clinical Protocols and Investigator Information.
See Investigational New Drug.
pharmaceutical abbreviation, investigational new drug (US FDA designation)
investigational new drug. an FDA classification applied to experimental drugs undergoing trials to assess safety and efficacy prior to marketing approval. IND status must be granted before a drug can enter Phase I testing. See also treatment IND, supplemental IND.
Investigational new drug. a drug that the FDA allows to be used in human clinical trials in order to gain information for evaluation by the FDA, usually for approval of commercial marketing.
Investigational New Drug. A drug permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.
Investigational New Drug Application. Also known as the Notice of Claimed Investigational Exemption for a new drug, this document provides sufficient data to establish that the drug has demonstrated a reasonable degree of safety that does not preclude its testing in humans.
Investigational New Drug: A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes. Investigational New Drug is a status given to an experimental drug after the FDA agrees that it can be tested in people.
investigational new drug; an application that is filed with the FDA before beginning testing in humans
Investigational New Drug application. Required by drug makers prior to conducting phase I - III clinical trials in the United States on humans.
Investigational new drug. A novel chemical substance used to affect the function of the mind or body with the intention of diagnosing, preventing, or treating a disease, a condition, or its symptoms. An IND is not yet FDA approved for marketing to treat a particular condition, but it must be investigated in clinical trials to gather data that FDA will consider for the marketing approval application.
the status of an experimental drug after the FDA agrees that it can be tested in people.
Investigational New Drug. an application to pursue clinical trials with an experimental drug that has passed pre-clinical trials.
Investigational New Drug. The notification of data relating to a new drug, which must be made to the FDA before it may be administered to man.
Investigational New Drug. An authorization given by the Food and Drug Administration (FDA) to administer a new drug, antibiotic drug, or biological drug to humans in a clinical trial. It also includes a biological product used in vitro for diagnostic purposes.
Investigational New Drug. An Investigational New Drug (IND) Application is a request for authorization from the FDA to administer an investigational drug or biological product to humans.
Investigational new drug. An IND application must be submitted and approved by a regulatory agency prior to clinical trials of an investigational (novel) drug in humans in the United States.
Abbreviation for "investigational new drug." An investigational new drug application by the FDA before a drug can be tested in humans in clinical trials.
Investigational New Drug: Regulatory submission to the FDA in order to receive permission to proceed with clinical trials in humans. An IND document contains data on preclinical studies (laboratory and animal experiments), toxicology, pharmacology, manufacturing, and quality control.
Investigational New Drug application (also synonymous with "Notice of Claimed Investigational Exemption for a New Drug"). ( CDER Guidance Document on Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs or 21 CFR 314.312.)
Investigational New Drug application. Notification by a drug sponsor to the FDA of its intention to conduct clinical studies on human subjects.
Investigational New Drug application, a proposal to the US Food and Drug Administration (FDA) to begin testing of a candidate drug in humans in order to assess its safety and effectiveness (efficacy).
investigational new drug. A drug that the Food and Drug Administration (FDA) allows to be used in clinical trials, but that the FDA has not yet approved for commercial marketing.
An IND (Investigational New Drug Application) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
Investigational New Drug application, submitted to the United States Food and Drug Administration (FDA) prior to the start of human clinical trials to demonstrate safety and efficacy. This application contains the results of animal pharmacology and toxicology studies, information about the manufacturing process, clinical protocols and investigator information.
Investigational New Drug. The notification of data relating to a drug candidate, which must be given to the FDA before it may be administered to patients in clinical studies.
Investigational New Drug Exemptions (Blood Bank)
Investigational New Drug, an application submitted to the FDA in order to begin testing a drug on humans. The IND shows results of previous experiments; how, where and by whom the studies will be conducted; the compound's chemical structure; proposed mechanism; toxic effects on animals; and manufacturing methods.
Investigational New Drug. Status given to an experimental drug after the Health Protection Branch ( HPB) approves an application for testing in volunteers.
A document filed with the FDA prior to clinical trial of a new drug. It gives a full description of the new drug, where and how it is manufactured, all QC information, etc. The IND is followed by a NDA (New Drug Application).