[perspective] if "secondary substitution (original research → imitation → original research)" occurs, measure the dissolution curve!

More than three years have passed since the full-fledged evaluation of the consistency of generic drugs The first batch of generic drugs purchased with volume will be on the stage of history this year As the price drop is too large, the "on the battlefield, whether it will drop the chain" has been concerned by all parties, that is, "whether the consistency evaluation of generic drugs will become a one-time evaluation of bioequivalence (be) test" has become the next focus of the industry Before that, two bid winning enterprises replied publicly to the above questions, but they were all unreliable, so I wrote a comment (see extended Reading-1 and 2 for details) Recently, the National Health Insurance Bureau issued the notice on the monitoring plan for the centralized procurement and use of drugs by state organizations In ensuring quality, the monitoring system was replaced by the two alternative measures, namely, the generic drug instead of the original research drug, and the clinical effect of the patient after taking the medicine was still suck and forced to exchange the original drug Read - 3,4) Therefore, I predict that if it happens, the in vitro dissolution behavior of the generic drug must be significantly different from that of the original drug At that time, I would also like to ask the relevant departments to inform me, let me test, analyze and deconstruct Because my research has been dissolved for many years, I have absolute confidence and assurance in my specialty, and I'm willing to contribute a little to the improvement of the quality of our country's generic drugs [tips] Why did the Japan food and Drug Administration launch the drug quality re evaluation project in 1998? In 1984, the U.S FDA launched be test, which was introduced into Japan in the same year About 10 years later, some generic drugs have shown safety ineffectiveness and side effects on the elderly, which are significantly worse than those of the original drugs Because the be test mostly uses young and strong men as subjects, the internal environment of such people is far from the elderly, so it is difficult to comprehensively and scientifically evaluate the quality of generic drugs In addition, the be test cannot be reproduced, and there is no practical way in the future To monitor the quality of generic drugs After receiving "a large number of reports" (it is reported that the country has the most complete clinical drug use monitoring system in the world), housheng province ordered the National Drug Inspection Institute to set up a project in 1993 to study "how to improve the quality of listed generic drugs", and formulated the technical means and regulatory measures "how to ensure that the quality of each batch of generic drugs in the future is consistent with the original research drugs" After years of research, the experts of the Institute put forward the "multi feature dissolution curve method", which was highly praised by housheng province So the project came into being When I arrived at the Institute in 2003 for further study, I saw that national pharmaceutical companies were carrying out in-depth research on preparations through multiple characteristic dissolution curves, so as to achieve the goal that generic drugs can replace the original research drugs with full confidence for all patients in clinical practice At the same time, the government drug Inspection Institute spot checked the consistency of multiple dissolution curves with the original research drugs to ensure the stability and sustainability of the quality of generic drugs, which was shocked and shocked by the great earthquake 。 It is said that "history is always strikingly similar", but I sincerely hope that China will not follow the mistakes of Japan [extended reading] 1) consistency evaluation "second half", how to ensure the quality of future generic drugs? 2) [exclusive] let's look at Mr Xie's sharp comments ∥ "another pharmaceutical enterprise official declared that" can the 4 + 7 winning products be so low price and product quality be guaranteed? " 3) The National Health Insurance Bureau issued the notice on printing and distributing the monitoring plan for the pilot work of centralized purchase and use of drugs organized by the state 4) "4 + 7" centralized purchase work has been monitored in an all-round way, and the document has been released! 5) [reverie or delusion? ]From "periodic table of elements" to "database of dissolution curve of multiple characteristics of original research drugs", it is stated that: the viewpoint of this paper only represents the author, not the position of yaozhiwang, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.