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This critical step in the drug approval process typically requires 6-12 months of intensive effort to assemble all the safety and effectiveness data generated throughout preclinical research and clinical trial phases

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10.1111/j.1469-7580.2009.01199.x 55 KangE

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10.1007/s10787-006-1531-7 116 SikiricP.SeiwerthS.BrcicL.SeverM.KlicekR.RadicB.et al (2010)

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