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Investigator's brochure. In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process ...
Phases of clinical research. The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. [1] For drug development, the clinical phases start with testing for drug safety in a few human subjects, then ...
Many simply capitalize the term "Institutional Review Board" as the proper name of their instance. Regardless of the name chosen, the IRB is subject to the US FDA's IRB regulations when studies of FDA-regulated products are reviewed and approved. At one time, such a committee was named the "Committee for the Protection of Human Subjects".
t. e. The United States Food and Drug Administration 's 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 electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
The office's primary duty is the implementation of 45 CFR 46, a set of regulations for Institutional Review Boards (IRBs) that mirrors the U.S. Food and Drug Administration (FDA) regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the guidance of the Federal Policy for the Protection ...
FDA: Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA Regulated Clinical Trials. This guidance describes the FDA policy that already-accrued data, relating to individuals who cease participating in a study, are to be maintained as part of the study data.
Bedaquiline, sold under the brand name Sirturo, is a medication used for the treatment of active tuberculosis. [1] Specifically, it is used to treat multi-drug-resistant tuberculosis along with other medications for tuberculosis. [1][8][9] It is taken by mouth. [3] Common side effects include nausea, joint pains, headaches, and chest pain. [1]