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FEATURED ARTICLES

• Considerations In Using Foreign Trial Data In U.S. NDA Submissions

  More and more drug companies are finding it financially advantageous to conduct clinical trials in foreign countries and to include data from these trials in NDA submissions. When offshore trials are properly conducted and the data is properly handled, this strategy can accelerate approval and lower the cost of drug development. By Ken Phelps, Camargo Pharmaceutical Services

• Getting To Proof-Of-Concept In Early Stage Clinical Research

  Every biopharmaceutical company today is striving to arrive at the Proof-of-Concept decision point for new treatments as quickly and cheaply as possible. Management is looking to identify potential winners and avoid costly late stage failures. By Sy Pretorius, Corporate Vice President and World-wide Head of Early Phase, PAREXEL International Corporation

• The Business Of Cultural Competent Research: The New Stakeholders

  For industry committed to delivering innovative healthcare, now is the time to take stock of the shift in population demographics and how cultural competence relates to developing new medicines through clinical trials. By James Gillespie and Kathleen Drennan

WHITE PAPERS AND CASE STUDIES

• Ethnic Bridging

  Clinilabs, a contract research organization (CRO), was selected to characterize the pharmacokinetic prole of XXXX following the administration of four doses of XXXX to healthy Japanese and non-Japanese subjects aged 20 to 45 years by assessing serum concentration data over time.

• Dry Blood Spot Analysis Datasheet ICON offers dry blood spot analysis as a convenient and practical solution when sampling from populations where sample volume is at a premium or where analyte stability is an issue.
• White Paper: Foreign Clinical Trial Data Given the high cost of moving a promising drug candidate through years of clinical trials, it’s no wonder that more and more drug manufacturers have begun conducting at least some of their clinical trials in foreign countries. With lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, but especially to those involved in generic and “fast-track” approval programs.

SERVICES AND PRODUCTS

Dry Blood Spot Analysis

ICON offers dry blood spot analysis as a convenient and practical solution when sampling from populations where sample volume is at a premium or where analyte stability is an issue.