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The 12th five-year plan for national drug safety issued by the state council clearly proposes to comprehensively improve the quality of generic drugs and carry out consistency evaluation of generic drugs quality. According to statistics, by the end of 2013, more than 4,000 drug manufacturers in China had 187,000 drug approval document Numbers. Among them, the approval number of chemical drugs is 121,000, and most of them are generic drugs. The rapid development of generic drugs in China has effectively solved the outstanding problem of shortage of doctors and drugs among the people and played an important role in maintaining public health.
At present, the quality of most generic drugs in China is uneven, good and bad coexist, and some of them are not equivalent. In order to ensure the safety and effectiveness of drug use by ordinary people, the state has pushed the idea and arrangement of drug consistency evaluation onto the fast track. Consistency evaluation is a systematic, complex and long-term process. How to effectively promote it is still a process of trial and error.
The reasons for the quality gap between generic drugs and the original developed drugs are as follows: in the case of the same prescription, ingredients and other external indicators, the differences in the design process, preparation process and other internal factors between generic drugs and the original developed drugs are enough to produce different clinical effects; On the other hand, for a long time, China has been one-sided emphasis on generic drug standard research, while ignoring the comparative research.
At present, the company has formed the SOP of consistency evaluation, which carries out in-depth research on many industrial pharmacy elements, such as the original preparation, the characteristics of raw materials, the impurity spectrum, the composition and characteristics of auxiliary materials, pharmaceutical equipment and process, preparation personnel, process amplification, etc., and can achieve multiple dissolution curves consistent with reference preparations.
The dissolution test of oral solid preparation is the core evaluation index, especially the evaluation method of whether multiple dissolution curves of generic drugs are consistent with the original developed drugs. Because this measurement is a data microscopic expression of all elements of the preparation (such as the characteristics of raw materials, auxiliary materials, preparation technology, preparation equipment, preparation personnel, etc.).
Only comprehensive and consistent evaluation studies should be carried out to achieve the consistency of in vitro pharmacology, in vivo bioavailability and clinical efficacy of the developed drugs and reference drugs.