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Streamline And Accelerate A Drug Development Plan Using The 505(b)(2) Pathway
2013-02-19 11:49:02| drugdiscoveryonline Downloads
An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.
Tags: plan
development
drug
pathway
Category:Biotechnology and Pharmaceuticals
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