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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
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
Office Open XML (OOXML) format was introduced with Microsoft Office 2007 and became the default format of Microsoft Excel ever since. Excel-related file extensions of this format include:.xlsx – Excel workbook.xlsm – Excel macro-enabled workbook; same as xlsx but may contain macros and scripts.xltx – Excel template.xltm – Excel macro ...
Microsoft's version of Wordpad included with Windows 7 supports opening and saving in the docx format. [22] The Mac OS X-based NeoOffice office suite supports opening, editing, and saving of most Office Open XML documents since version 2.1. [23] Nisus Writer Pro has built-in, but rather limited, support for opening OOXML documents.
By Brendan Pierson (Reuters) -Major food companies, including Kraft Heinz, Mondelez and Coca-Cola, were hit with a new lawsuit in the U.S. on Tuesday accusing them of designing and marketing ...
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
Word on the mountain has it that Lindsey Vonn is still fast through a downhill course, even at 40 years old. On a frigid Friday morning, Vonn darted through the shadows along the speed course at ...
As Radakin defined it, the first nuclear age was during the Cold War, when the U.S. and Soviet Union amassed colossal arsenals and were “governed by the risk of uncontrollable escalation and the ...
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