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PAREXEL International Corporation, a global biopharmaceutical services provider, today announced that the Company is among the first to conduct a Chinese bridging study outside of China.
PAREXEL EXPANDS PIONEERING ASIAN ETHNOBRIDGING EXPERTISE
Boston, MA, November 6, 2008 – PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that the Company is among the first to conduct a Chinese bridging study outside of China. PAREXEL is a leader in providing Asian bridging studies, which are conducted in early clinical development to help biopharmaceutical companies prepare strategic global plans, gather relevant ethnic data in the U.S., and save time and development costs for programs in Asia. PAREXEL's California Clinical Trials (CCT) pioneered the ethnobridging study, which is a pharmacokinetic study designed to determine safety and tolerability as well as possible pharmacokinetic differences in a target ethnic population.
The Chinese bridging study was conducted at PAREXEL's dedicated research unit in Los Angeles, California, which provides access to large first generation Asian populations, including 500,000 Chinese, as well as 600,000 Korean and 40,000 Japanese people. This type of study supports biopharmaceutical companies that currently face challenges in conducting early phase studies in certain countries within the Asia/Pacific region, such as China. Phase I clinical data that are gathered in the U.S. can be used for subsequent global trials that include China, or for China registration. PAREXEL's Asian bridging studies also provide clients with options for parallel development in Western and Asia/Pacific geographies. In addition to the Chinese bridging study, PAREXEL has completed Korean and Japanese bridging studies.
"With Japan projected to maintain its position as the second largest pharmaceutical market globally, and China positioned to become the sixth largest market by 2010, the Asia/Pacific region includes important end markets for our clients. To meet increasing client demand for global development programs that include the Asia/Pacific region, we are expanding our ethnobridging study capabilities to expedite early phase approval of compounds in Asia and the Western hemisphere,” said Michelle Middle, MB, ChB, Corporate Vice President and Worldwide Head of Clinical Pharmacology at PAREXEL. "PAREXEL's Asian bridging study expertise is focused on helping clients make earlier informed decisions and maximize the return on their product development investment, while rapidly bringing safe, effective treatments to patients in the Asia/Pacific region.”
Through the acquisition of CCT in 2006, PAREXEL expanded its capabilities in International Conference on Harmonization (ICH) bridging and ethnic sensitivity study development, including Japanese bridging studies. Japan's regulatory authority has collaborated with PAREXEL's clinical pharmacology experts to establish a high standard for conducting Japanese pharmacology studies outside of Japan. PAREXEL has completed more than 40 Japanese bridging studies, and has the largest number of qualified volunteers outside of Japan in its database.
PAREXEL's ethnobridging study work has been widely published in peer-reviewed journals and books. The recently published book Accelerating Global Drug Development: The Science and Practice of Ethnobridging was authored by several PAREXEL experts, including Stanford S. Jhee, Pharm.D., Senior Director of Research, Clinical Pharmacology, PAREXEL, a renowned authority on ethnobridging studies.
PAREXEL's clinical pharmacology services support numerous therapeutic areas including highly specialized areas such as pain modeling, sleep polysmnography, glucose clamp, and respiratory challenge research. For more information about PAREXEL's early phase development capabilities visit: http://www.parexel.com/early_phase.html.