Articles
Placing Preclinical GLP Studies in China: Questions and Answers to Help You Decide
September 8, 2008 |
A White Paper Presented by |
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Whereas 10 years ago no one thought about placing GLP-compliant preclinical studies in China, soon every biopharma company preparing an IND will take China into account, where GLP study costs are lower, studies can often start sooner, and access to animal models is easier. Right now, however, with GLP studies in China so new, companies considering China have many questions. For example, “Can China really meet western GLP standards?” Answer: Absolutely. The FDA recently accepted a GLP nonhuman primate toxicology study performed at Bridge China. “Are reports in clear, standard English?” Yes. “Is it easy to ship bioanalytical samples from China to the US?” Answer: Usually, yes, but shipping samples for certain species requires a special permit and careful planning to avoid delaying your schedule. As the first company to offer western-level GLP-compliant preclinical study services in China, Bridge Laboratories receives these questions and many others every day. To help you consider your China options from an informed perspective, this white paper contains our answers to the questions we receive most often. Read more...
Updates on Preclinical Development in China
August 19, 2008 |
By: Ernie Bush, PhD and Eric Meyers, MBA |
Cambridge Healthtech Associates (CHA) |
Three years ago there were few if any western firms doing preclinical testing in China, but today there are already dozens, and within the next few years this will be commonplace – much as chemistry outsourcing is today.
Drug developers of all sizes are re-examining their assumptions about their true core competencies, i.e., what should be done internally and what can be better accomplished through specific outsourcing relationships (see the recent Lilly-Covance deal). Read more...
There's More Than Meets the Eye to China's CRO Sector - Experts
July 9, 2008 |
By: Karen Tye |
interfax |
Part of China's appeal to foreign investors has always been its cost advantage, but according to pharmaceutical industry experts, the contract research organization (CRO) sector in China is more that just a cheaper outsourcing destination.
R. Stephen Porter, CSO of Medicilon-PI Preclinical Research Shanghai, explained that most venture capitalists and multinational companies that have established their own R & D centers in China are not here for the cheap labor. Read more...
Offshore Opportunity on the Rise
Mar 1, 2008 |
By:Jim Miller |
BioPharm International |
China continues to get a lot of bad press for quality problems with some medications and other consumer products manufactured there, but its popularity as a place to conduct biopharmaceutical research continues to grow. The major clinical research organizations (CROs) are racing to get established there, as much to stay a step ahead of the competition as for the immediate opportunity. Read more...