Quality of Regulatory Decision-Making Practices: Issues Facing Companies and Agencies

被引:0
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作者
Magdalena Bujar
Neil McAuslane
Sam Salek
Stuart Walker
机构
[1] Centre for Innovation in Regulatory Science (CIRS),Department of Pharmacy, Pharmacology & Postgraduate Medicine
[2] University of Hertfordshire,School of Pharmacy and Pharmaceutical Sciences
[3] Institute for Medicines Development,undefined
[4] Cardiff University,undefined
关键词
quality decision making; framework; new drug application; submission and approval; regulatory agency;
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摘要
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页码:487 / 495
页数:8
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