tory burch shoes Biological agents, safety, how _3

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Biological agents,[link widoczny dla zalogowanych], safety, how

On the Biological agents, is defined as antibodies, enzymes, hormones or other biological sources extracted from the production or preparation. Biological agents has become a very important treatment, and has made rapid progress. Since 1982, there were already more than 250 biologics approved listing. In the article published in JAMA, Giezen ~ H his colleagues wrote in the article, from 2003 to 2006, by the United States and the European Union Drug Administration approved a new drug in the sector were 24% ~ N22% of biological agents, biological preparation is a special risk, relatively new drugs, such as with the antigen, may cause the immune response. However, with regard to biological agents in terms of security issues also poorly understood. Giezen and his colleagues from January 1995 ~ June 2007 between the U.S. or the European Union approved the listing of biological agents in a number of biological products screening, investigation and safety of their regulatory decisions related to the nature and probability. The survey not included in the vaccine, allergies caused by the product (ie a substance capable of causing allergic reactions), further processed products and products used for transfusion purposes. In the past l2 years and a half years, the United States and the European Union approved the l36 and 105 kinds of biological agents listed,[link widoczny dla zalogowanych], including 67 kinds of biological agents in these two regions are given batch, that is, a total of at this time 174 kinds of biological agents to obtain market approval. January 1995 ~ 2OO8 period in June, the relevant departments of these 41 species (23.6%) made a 82 on drug safety and regulatory adjustments, including 46 medical professionals to the United States a written letter , 17 medical professionals to the EU sent 19 letters and Regulatory and safety-related decision-making adjustments to an average of 3.7 years, about 7O. 7% of these biological agents made 5 years after approval. Biological agents for the first time for the adjustment of security-related probability are: the approval of 14% after 3 years, approval within 10 to 29%. The first class of biological agents to be approved, requiring adjustment of the first security control in the incidence of late than the kind of biological agents to be approved by a higher incidence. Regulatory decisions in the adjustment of 82, 26.8% and the general classification and treatment of organ diseases related sites, 22% with infection, 15.9%, and immune system diseases, l2.2% with benign, malignant, or unknown nature vegetation related. Part of the safety and medication issues, the main reason is parenteral administration (intravenous or intramuscular injection) infusion reactions occurred, but also most of the parenteral administration route of administration of biological agents. Of biological agents for more in-depth study may be predicted in the development stage to some security issues. The authors believe that,[link widoczny dla zalogowanych], despite the recognition of pre-clinical trials of biological agents has limitations, but the results from pharmacology studies, the results of preclinical studies and clinical results of the study may be able to predict the risk of drug-related, but also in the drug approval After the close of the monitoring of these risks. Medical professionals should also be aware of these relatively new special risks of biological agents. Editor CatherineD. DeAngelis, MD, ffAMA executive editor of the Chicago office PhilB. Fontanarosa, MD, wrote a commentary for the article,[link widoczny dla zalogowanych], the paper pointed out that after the evaluation of new drug approval and market areas also need further improvement. MSCE, such as Giezen research shows, many drug safety problems are discovered only after the listing, the body is always in a state of change, the impact of many drugs in the drug use is often apparent only after a period of time . In addition, some rare serious side effects that often require a large number of patient samples was able to confirm this. In order to obtain FDA approval for clinical trials, is often selected a particular object of study, and a limited number of drugs not reflect the true security. And test operations will be the impact of pharmaceutical companies, which may obscure the real security problems of drug. They concluded that the current drug approval process is not perfect, flawed system of drug administration, drug and medical equipment monitoring is still not perfect. If the system is still not corrected these deficiencies, the patient is inevitable because of the use of new drugs and hurt the market. One (Source [link widoczny dla zalogowanych] compile HUANG Yan) 101 China Prescription Drug 200810No79
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