PAREXEL ETHNOBRIDGING EXPERTS INTRODUCE NEW EDITION OF ACCELERATING GLOBAL DRUG DEVELOPMENT
Boston, MA, September 29, 2011—PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider and an innovator of the ethnobridging study, today announced the publication of the new edition of Accelerating Global Drug Development: The Science and Practice of Ethnobridging. The book, which has served as the definitive reference for global drug developers dealing with ethnically sensitive clinical programs since 2002, focuses on accelerating development for the Asia/Pacific market and saving time and cost for early phase programs.
The expanded edition addresses the increasing importance of Asian countries in global development strategies and the registration of drugs in the Asia/Pacific region. The book reviews the advantages of an ethnobridging study, which is an approach to determine safety and tolerability, as well as possible pharmacokinetic and pharmacodynamic differences in target ethnic populations.
“Asian markets, particularly Japan, China and Korea, offer tremendous growth opportunities for the biopharmaceutical industry. In early phase development programs for Asia, global and regionally-based biopharmaceutical companies, especially in Japan, increasingly gather diverse ethnic data during Phase I. Our book focuses on market dynamics in the Asia/Pacific region and their impact on early phase development programs,” said Lead Author Stanford S. Jhee, Pharm.D., Senior Director of Research, Early Phase, PAREXEL and a renowned authority on ethnobridging studies.
The authors include Dr. Jhee and his colleagues, Mark Yen, M.D., Samira Moran, B.S., and Larry Ereshefsky, Pharm.D, F.C.C.P., B.C.P.P. These PAREXEL early phase experts have updated the book with international regulatory and development trends. New content in the book examines approaches for entry into China as well as innovative strategies for development in Japan. Scientific data on pharmacokinetics and pharmacodynamics and regulatory perspectives from FDA, ICH and NIH are presented throughout the book as they pertain to these issues.
PAREXEL experts have worked closely with Asian regulators to design studies, conducted outside of Asia for acceptance by the Asian regulators, that adhere to the International Conference on Harmonization (ICH) E5 guideline. PAREXEL provides consultation on regulatory issues, protocol designs and analysis of data, as well as study conduct, with relation to ethnobridging studies. The Company has a proprietary database and a dedicated enrollment team with experience in various specialized recruitment methods and access to some of the largest populations of first-generation Asians outside of Asia in both the U.S. and Europe. For more information about PAREXEL's early phase capabilities and Accelerating Global Drug Development: The Science and Practice of Ethnobridging visit: http://www.parexel.com/services-and-capabilities/early-phase.
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About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 52 countries around the world, and has approximately 10,550 employees. For more information about PAREXEL International visit www.PAREXEL.com.
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