{"id":310,"date":"2013-09-06T10:45:20","date_gmt":"2013-09-06T08:45:20","guid":{"rendered":"http:\/\/www.ideal.rwth-aachen.de\/?page_id=310"},"modified":"2013-09-06T14:05:38","modified_gmt":"2013-09-06T12:05:38","slug":"wp3-extrapolation","status":"publish","type":"page","link":"https:\/\/www.ideal.rwth-aachen.de\/?page_id=310","title":{"rendered":"WP3 \u2013 Extrapolation"},"content":{"rendered":"<\/div><\/div><\/div><\/div><\/div>
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WP3 \u2013 Extrapolating dose response information to small populations<\/h4>
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The primary goal of the WP is a rigorous statistical methodology for extrapolation of dose response information and conclusions available from a given source population to make inference for another target population which is much smaller in size. We will address issues raised in the CHMP Concept Paper on extrapolation of efficacy and safety information in drug development [CHMP 2012] and develop better methodologies for medicinal drug development that avoid unnecessary studies in the target population for ethical reasons, for efficiency, and to allocate resources to areas where studies are the most needed.
\nAlternatively, in situations where the feasibility of studies is restricted, the new methodology can be applied for rational interpretation of the limited evidence in the target population in the context of data from other sources.<\/p>\n

The main objectives in this context are:<\/p>\n