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. 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.
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 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. 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.
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: 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, 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, 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.
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).
ind allows you to indent output from a sub-process, which is useful for scripting. It has been ested with FreeBSD, NetBSD, OpenBSD, Linux, Solaris, and Mac OS X on x86, AMD-64, Alpha, SPARC32, SPARC64, and PPC.
Index files are produced by the MakeIndex and automatically get included into your LaTeX document wherever you put the \printindex command. The \index commands in your LaTeX document write raw indexing data to the IDX file. MakeIndex reads the IDX file, sorts and formats the index according to the IST file, and produces an IND file for your document.