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Results for: Phase II/III - Regulatory & Quality

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  • Population PK/PD - Modeling and Simulation Optimization Tools

    Brochure — February 11, 2011
    Population pharmacokinetic/ pharmacodynamic (PK/PD) modeling and simulation, available from Quintiles, is now endorsed by the FDA as often being instrumental in drug approval and labeling.

  • Regulations for Clinical Studies in Pediatric Patients in the European Union

    White Paper — March 10, 2010
    After the United States issued pediatric drug study requirements, the European Union (EU) passed a regulation that created major changes to clinical studies for pediatric

  • PharmAsia News Article Reprint

    Media Coverage — March 1, 2010
    Quintiles Asia Executives Say CROs Must Evaluate, Adjust To New Health Landscape: An Interview With PharmAsia News.

  • Journal for Clinical Studies

    Hear from the Experts — February 19, 2010
    In the January 2010 Journal for Clinical Studies, Dr. Erica Caveney and Dr. Rick Turner analyze the FDA Guidance on diabetes drugs and cardiovascular risk.

  • Sub-Saharan Africa Phase II/III Fact Sheet

    Brochure — July 29, 2009
    Sub-Saharan Africa fact sheet about Phase II/III trials. The gateway to Africa: Access to expanded clinical resources and patient populations in South Africa and beyond.

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