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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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