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CHMP/EWP/2459/02: Methodological issues in confirmatory clinical trials planned with an adaptive design [33] (EMA) focuses on the opportunities for interim trial design modifications, and the prerequisites, problems and pitfalls that must be considered as soon as any kind of flexibility is introduced into a confirmatory clinical trial intended ...
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 Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis
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 ...
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The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
A military police officer has been arrested in Brazil after a video emerged of him throwing a civilian over a bridge in Sao Paulo on Monday, sparking protests in the city.
General Hospital just bid goodbye to a major character.. During the Friday, Dec. 13 episode, fan-favorite Dex Heller, played by Evan Hofer, met his demise. Dex had been expected to make a full ...