Drug-Drug Interaction White Papers & Case Studies

1. Considerations When Selecting A CRO For Phase I Clinical Studies 6/17/2013

   Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.

2. Streamline And Accelerate A Drug Development Plan Using The 505(b)(2) Pathway 2/19/2013

   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.