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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 and is updated with new ...
"Unexpected" means that for an authorised (approved) medicinal product that the event is not described in the product's labeling, or in the case of an investigational (yet to be approved or disapproved) product that the event is not listed in the Investigator’s Brochure. That is, the AE is unexpected for the drug or device. [citation needed]
All study investigators are expected to strictly observe the protocol. [citation needed] The protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations and organization of the planned trial. Details of the trial are provided in documents referenced in the protocol, such as an investigator's brochure.
In medical research, an Investigator's brochure (IB) is a summary of previously established facts and information compiled by the researchers to guide the conduct of a drug trial. Goal is to gather the information to ensure that no previously-known dangers are overlooked in planning the study and so that information is on-hand in the event of a ...
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.
Clinical investigator; Clinical research associate; Clinical research coordinator; Clinical significance; Clinical study design; Clinical study report; Clinical trial; Clinical trial management system; Clinical trial portal; Clinical trial registration; Clinical trials publication; Clinical trials unit; Cluster-randomised controlled trial; Code ...
It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors.
Theralizumab (also known as TGN1412, CD28-SuperMAB, and TAB08) is an immunomodulatory drug developed by immunologist Thomas Hünig of the University of Würzburg.It was withdrawn from development after inducing severe inflammatory reactions as well as chronic organ failure in the first-in-human study by Parexel in London in March 2006. [1]