ICON has received industry accreditations for three of its laboratories. The company’s bioanalytical lab in Manchester, UK received GCP and GLP accreditation from the MHRA (Medicines and Healthcare products Regulatory Agency), covering bioanalysis of small molecules by mass spectrometry and large molecules by immunoassay techniques. In addition, ICON’s clinical pathology lab in Manchester has received GCP accreditation.

Also, ICON’s Central Lab in Singapore has received NGSP (National Glycohemoglobin Standardisation Program) Level I Certificate of Traceability for successfully completing bias testing using specific methods and instrumentation, reagent lots and calibrator lots. ICON now has NGSP Level I Certified labs in Farmingdale, NY, Dublin, Ireland, Singapore and Bangalore, India.

Peter Gray, ICON’s chief executive officer, said, “We pride ourselves on the strength of our science and the quality and reliability of our lab testing. Having a global network of industry-accredited labs provides clients with the reassurance that their samples will be tested according to the highest industry standards and techniques which in turn will deliver quality results.”

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GlaxoSmithKline and XenoPort, Inc. achieved positive results from a Phase IIb trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults.

The 14-week, double-blind, placebo-controlled study enrolled 376 subjects with PHN. Subjects were randomized to receive placebo, 1200, 2400 or 3600 mg/day of the drug, dosed twice a day. All doses of GSK1838262 demonstrated statistically significant improvements over placebo on the primary endpoint, which was the change from baseline to the end of maintenance treatment in the 24-hour average pain intensity score.

“We are encouraged by the positive results in this study of GSK1838262 in treating neuropathic pain associated with PHN, which is a debilitating condition for affected patients. We look forward to sharing the full results at a future medical meeting,” said Atul Pande, M.D., senior vice president, GSK Neurosciences Medicines Development Center. “We are currently evaluating the next steps for the development of this compound for the treatment of neuropathic pain.”

The drug was generally well tolerated at all doses in the study. The most common adverse events were dizziness and somnolence; most were mild or moderate in intensity.

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QPS Taiwan has been awarded a GLP lab certification by the Department of Health (DOH), Executive Yuan, R.O.C. (Taiwan). QPS received this certification based on their scientific infrastructure, including global SOPs, understanding of the regulatory agency requirements, and planning for the implementation of systems and processes within the Taiwan facility.

“QPS Taiwan has been awarded the first and only GLP lab certification by DOH, Taiwan for bioanalytical services supporting preclinical and clinical research,” said QPS Taiwan president and chief executive officer, Vincent Yen, M.B.A. “QPS Taiwan shares the same quality criteria, global SOPs, lab procedures, equipment (API 4000 triple quadrupole mass spectrometers, Shimadzu VP-series LCs, Tomtec Quadra), lab operations (Rees Monitors, Watson LIMS systems), and systems and processes as QPS U.S.A. We are excited about this certification, and are looking forward to continuing our partnership with U.S.A. based, E.U. based, and local pharmaceutical sponsors.”

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