Ethnobridging

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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

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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.
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.

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Phase III Data Show Greater Compliance Across Demographic Groups With Agile Therapeutics' Contraceptive Patch Compared To An Oral Contraceptive
Agile Therapeutics presented findings from a phase III pivotal trial of AG200-15, Agile's investigational once-weekly combination contraceptive patch containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG).
Abbott Presents Positive Results From Phase 2 "Pilot" Study Of An Interferon-Free Combination Regimen For The Treatment Of Hepatitis C
Abbott (NYSE: ABT) and Enanta Pharmaceuticals announced complete data from the study known as "Pilot" – Abbott's initial interferon-free study of its direct-acting antiviral agents for the treatment of hepatitis C (HCV) – showing that 91 percent of genotype 1 infected, treatment-naive patients taking ABT-450/r and ABT-072 combined with ribavirin administered for 12 weeks, achieved sustained viral response at 24 weeks (SVR24).
Abbott To Present Positive Phase 2 Results From Multiple Interferon-Free Studies Of Combination Regimens For The Treatment Of Hepatitis C
Abbott (NYSE: ABT) will present clinical trial results from two different interferon-free, Phase 2 studies for the treatment of hepatitis C (HCV) at the International Liver Congress™ 2012 (ILC 2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain.
Many Cancer Rates Continue To Decline Death rates from all cancers combined for men, women, and children continued to decrease in the United States between 2004 and 2008.
Lilly Steps Up Efforts To Improve Diversity In Clinical Trials Racial and ethnic minorities are more likely to develop cancer and die from it than the general U.S. population.
PAREXEL Achieves 100th Asian Ethnobridging Study Milestone PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, announced today that it has achieved a significant milestone by completing its 100th Asian ethnobridging study, which is designed to help biopharmaceutical companies accelerate development for the Asia/Pacific market.

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