Humanized medicines are far and close to us

Humanized medicines are far and close to us
Research and develop at the the policy and international summit forum of practice in 2008 new medicine that October 17 hold, the overseas-funded enterprise has introduced the idea with new medical field. The development in the whole world of individualized medicines and humanized medicines of biological mark are a newer topic. The reason why this concept appears, because some medicines may not be totally suitable for the large-scale crowd, but may be very effective to the particular crowd, help them to get rid of the puzzlement of disease. It develop it is new way medicineses humanizeds new medicine last living beings and last target to technology, the general therapeutic way is mainly for diseases and symptoms at present. But new technology makes us have more chances to adopt to develop new medicine with different methods now. For example, if a patient needs to resist the hypertension or medicine against cholesterol now, we begin from medicines A first, then see it will be effective, and then see medicines B, develop new medicine according to this roller chain. Developing the cost faced like this is the disappearances of time, money and patient's welfare. And we will adopt more individualized method in the future. Can take way that diagnose, use no matter biological the intersection of mark and thing or genetic mark, confirm that treats the best medicines of disease by combining the situation that is diagnosed. Understand needing biological mark of gene or intervention of a kind of medicines of a disease to be paid close attention to by increasingly many supervision guides of the supervision department, because they have very strong specificity, sensitiveness and regeneration, but the view of humanized medicines can use the idea of the biological mark of gene. To the development of these individualized medicines, should understand the supervision department hope which effective data biological pharmacy industry submits. Especially consider which effective data can promote such fast conversion from two to three while changing. Idea researched and developed together to have increase, diagnose function change existing curing decision medicine to some prospective medicine, we need the idea researched and developed together, then let the research and development standard of new medicine can coordinate to unify better in different areas. If has already launched different research and development in different fields at present, but does not unify so nonsensically as the coordination. FDA guided enterprises and declared in data 2005 FDA issued the first rule related to genetic sign, it tell enterprise how report come up genetic data, related to products sign, this involves anything and is named declaring voluntarily, that is to say the relevant data can not be hesitated to hand in, though the data of these genetic labels are still very preliminary and still very primitive, will not influence examining and approving to pass. Europe made a preliminary guide too at the beginning of this year, namely what European Union medicines administration bureau issued involves the course that the biological mark thing authorizes, this is a greater progress, but it is a draft that has not come into force finally. Research and develop humanized medicines, except having rules of the supervision department, the case of developing some effective biological mark things is very necessary too. We call upon medical enterprises to cooperate with government's hygiene, medicines superintendent office, for example we have a collaborative project with FDA of U.S.A., among them involve diagnosing the joint development of reagent. In addition we have a biological mark project about security of medicines, have 16 enterprises' participation, it is a biological mark of the security to some key human organs. For example renal security mark, because some kidney trouble treatment means is harmful to kidney and organ frequently, so should find about the renal security sign. If a kind of medicines make renal clearance ability reduce, will produce very great danger, we need such a biological mark thing, can assess the security of medicines better in such biological mark. Indicate in the renal security living beings we have several labels that can offer FDA to to judge in respect, we have done the relevant clinical trial, has input the database of the clinical trial for this, this is very successful. It is not that a actually biological mark thing of brand-new content is not a brand-new thing, it is to involve the content that the medicine gene studies that we have some examples, it is very helpful for this pair of patients and doctors to select and most suitable for the patient's means of making a diagnosis. Such as the west of card horse being flat, this kind of medicine is used for treating epileptics and nerve disease, it is medicine long long ago invented. Find side effect of it to be very large later, seem crowd can common in Asia, it is more likely to appear to take to the card Ma XiPing's Asian patient. Having found a kind of gene which adds HIAB1502 number in Taiwan, the existence that the patient that the great majority presented the bad reaction finds 1502 genes. This kind of living beings indicates that can be regarded as and made a diagnosis the basis consulted. Certainly the research in this respect is very complicated. That is to say if one patient take card appear 1502 gene after the the west flat horse, should change other medicines. It is flat to the west of card horse a is thought old medicine very effective in cure for a long time in this way, before there is no genetic technology, the living beings mark technology, people do not know what patient will have this kind of bad reaction, but there are biological marks this new technology now and can be judged when appearing, enterprises can give the data to the supervision department, the supervision department can make more scientific decision. Humanized medicines very much remote very much close from us, a realistic example is very clearly spoken already. Humanized medicines are far and close to us! The materials are connected: What is called biological mark thing, gain knowledge to carry on research through genomics and tumour group, find the biochemical index of a certain characteristic in an ordinary physiology or pathology or treatment that is suitable for determining and appraising objectively, process in the biological process that can know the organism lives in at present through it. Utilize the biological mark thing to research and develop the transition that medicines actually researched and developed the thinking. The new medicine research approach conventionally is to carry on the basic research first, and then find from a large number of compound sample storehouses that there is compound of pharmacology activity, then steps such as research, clinical trial,etc. before carrying on chemical structure optimization and design, clinical. Usually select compound with pharmacology activity and is less than one from 10,000 compounds, there are less ones that can reach clinical trial. Can change into since disease is studied now, study the principle of disease, understand the area with influence, have research and screening of target tropism. To determine ability may raise screening efficiency of guide compound fine target, also can judge the more accurately one to medicine validity at clinical research stage in early days. This edition article is interviewed and written red forever by staff reporter's king Su flat yellow Wei gold besides signing

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