Pharmaceutical companies and approved, are still in production, circulation. In 2007 'Drug Registration' revised, to a certain extent, regulate generic drug approval process. However, the standard has not yet completely solved the problem of too low. For example, whether to choose original study medicine as generic objects determine the efficacy of generic drugs, but this approach permits can not be obtained at the time of the original drug, the choice has been listed as a reference re-made generic drugs generic. Take generic drugs as generic standard, easily lead to 'more like the imitation.' MEET say, this is difficult to achieve generic drugs consistent with the original study medicine 100%, every imitation may bring 20% of the cumulative error, if the imitation of the lower, original research on drug efficacy stray farther. 'Drug Registration' to allow generic drugs to get to do benchmarking, partly out of frustration. Early, imported drugs is difficult to obtain, the lack of legal means to obtain the original drug, under a last resort, had to allow pharmaceutical companies to generic drugs as the generic standards. However, this vulnerability is exploited numerous pharmaceutical companies. Food Drug Administration Center for Drug Evaluation Distinguished experts Cheng Lurong revealed, like Carvedilol, Enalapril maleate tablets and other preparations, the domestic market has the original drug, a number of reporting institutions to submit the test has not been selected. FDA published a special 'Orange Book' as the 'gold standard', enter all the original drug patent expires, generic companies must choose a predetermined generic object. China has no similar 'gold standard.' For generic drugs efficacy judge also appeared astray. Analyzing generics and original drug efficacy are the same, the main basis for Chinese regulatory authorities in vitro dissolution profile, if the number of generic drugs in vitro dissolution curves are consistent with the original study medicine, then the probability of both consistent bioavailability of 90%. Standard Test Method for in vitro dissolution curve is simulated in a container of human stomach environment, then put medicines, measuring the dissolution profile, this standard allows a large number of generics Xianchuyuanxing. According to 'China Pharmaceutical News' reported that the 2008 National Assessment of sample testing, we found the prevailing quality standards, the first seizure of generic drugs almost 100 percent qualified, but not a generic vitro dissolution profile of drugs is consistent with the generics, and quite part of the drug solution
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