Search results
Results From The WOW.Com Content Network
Schreibchen 1.0.1 for Mac OS X can open and write Office Open XML text documents. It is a very simple word processor for disabled persons, children and other peoples that can not use (or like) other word processors or text editors. [26] Schreiben 4.0.1, a simple and fast word processor for Mac OS X supports Office Open XML text documents. [27]
Office Open XML (OOXML) format was introduced with Microsoft Office 2007 and became the default format of Microsoft Word ever since. Pertaining file extensions include:.docx – Word document.docm – Word macro-enabled document; same as docx, but may contain macros and scripts.dotx – Word template.dotm – Word macro-enabled template; same ...
This was soon followed by the FDA's statement of preference for SEND datasets. In December 2014, the FDA CDER and CBER divisions released guidance for industry enforcing the usage of SEND as part of Investigational New Drug (IND) and Biologic License Application (BLA) submission to the US Food and Drug Administration. All studies started after ...
Office Open XML (also informally known as OOXML) [5] is a zipped, XML-based file format developed by Microsoft for representing spreadsheets, charts, presentations and word processing documents. Ecma International standardized the initial version as ECMA-376.
A basic package contains an XML file called [Content_Types].xml at the root, along with three directories: _rels, docProps, and a directory specific for the document type (for example, in a .docx word processing package, there would be a word directory). The word directory contains the document.xml file which is the core content of the document.
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 ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.