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Rose to the challenge and knock the United States of China's preparations - preparations, China by ayay wang
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Rose to the challenge and knock the United States of China's preparations - preparations, China by AYAY WANG
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| Article Posted: 06/14/2010 |
| Article Views: 141 |
| Articles Written: 2282 - MORE ARTICLES FROM THIS AUTHOR |
| Word Count: 790 |
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Rose to the challenge and knock the United States of China's preparations - preparations, China |
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Business,Business News,Business Opportunities
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"Internationalization of the domestic competition and international competitiveness of domestic technology." This trend is to the API Enterprises in particular. Today, China Preparation Enterprises are with action impresses the judge: There are more than 20 Preparation European and American companies waiting drug administration certification, in order to win international subcontracting opportunities.
Products required for the U.S. market
United States is the original power of innovative drug research, choose what kind of products into the U.S. market can be said to knock on the door of the first tone. Shiny early for the industry in addition to known Tasly Danshen Dropping Pill, there Jiangsu Kangjin edge medicine compound Traditional Chinese medicine Guizhifuling capsule and the Pharmaceutical Group subsidiary Shanghai Xinyi Pharmaceutical Factory of Bifico capsule (Bifidobacteria in preparation). The former end of the year will be completed in the United States clinical trial, which enters phase clinical trial, will be the first declaration of microbial agents in the United States.
It is understood that Hong Yuan in 1996 when the two candidates selected varieties of products, a migraine, and the other the treatment of female endocrine disorder. The study found that treatment of migraine drugs in the U.S. market more, and treatment of gynecological diseases, not much variety, but results are not ideal, decided to opt for the latter, and the locking of this disease in women with primary dysmenorrhea on. In 2004, upon application to the FDA, in April 2007, the varieties granted access clinical trial. 8 in the United States after the clinical trial centers on recruitment of volunteer time, and soon reached its planned size, test rapidly.
The use of the positive effects of probiotics has been recognized by industry experts, but how Antibiotic The principle of joint use remains to be established. Shanghai Xinyi Pharmaceutical Changfuchangchang Chen Binhua senior engineer, said they and other six countries that have a U.S. patent on the application of drug are also being carried out the work.
According to reports, FDA officials had to enterprise evaluation, Hsin Yi has also begun a joint use of antibiotics in the test rather than the same time.
Carefully prepared in order to stabilize win
Not just the United States are approved to carry out clinical trials difficult, and once approved, it must start within two years, the cost is high. According to statistics, 3 clinical trials about 10 billion yuan, and the average elimination rate of 95%, still not sure whether the listing. In view of this, China Pharmaceutical companies In the context of limited resources, chose the product is not enough, but also navigating through the FDA's requirements in order to increase the rate.
Chen Binhua said that in the application process has strong feelings that the FDA's scientific attitude, live Q & A of the staff have higher demands.
Hong Yuan approved in 2004 to enter phase clinical trial, but they did not start immediately, but spent nearly two years to choose a drug test herbal and gynecological experience CRO company, as well as familiar Traditional treatment of clinicians and understand Chinese and Chinese American lawyer. "Now we are experts in the United States not to send the staff a lot of preparation is relatively high and relatively smooth conduct follow-up." Hong Yuan researchers said.
Open cooperation and sharing market It is understood that the completion of phase clinical trial of Hong Yuan will start in the next phase clinical trial, which is time-consuming, the largest capital investment, while there is great risk stage. Hong Yuan Cheng Group deputy general manager who told us that they clinical trials in the period spent about 80 million yuan, clinical trial will cost more, do this, Hong Yuan will cooperate with other companies. At present, several U.S. companies to negotiate.
Fact, adopt a cooperative attitude, at least in the capital and in the future market development on some shared. At present, China pharmaceutical companies seeking funding channel is wide, especially in the final phase of the trial were eligible for the funds obtained favor. But the Chinese pharmaceutical companies also lack experience in the United States to promote, develop and mature the market is often prepared late in the trial progresses. Therefore, the selection of partners is not only financial strength to see whether the other side, more needs to develop capacity of the local market. I am a professional editor from Chinese Manufacturers, and my work is to promote a free online trade platform. http://www.chinaqualitycrafts.com/ contain a great deal of information about fire wood processor , biodiesel manufacturing plant welcome to visit!
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