Progress and Challenges of Reference Standard and Its New Form: Digital Reference Standard

Number and quantities of reference standards (RS) needed for the quality control of drugs are increasing, bringing great pressure to the calibration and using company. This manuscript summarized the four generations for the development of RS including physical RS, paper atlas, and electronic databases. The advantages and disadvantages of each generation were summarized. The concept of digital RS (DRS) was proposed based on this, and summed up the definition, advantages, and technical architecture of DRS. The 10 characteristics of five aspects of the DRS were discussed including digital, multi-dimension, big data, cloud computing, internet, internet of things, sharing, multi-terminal, intelligence, and compliance certification. Then, the necessity of its formation and application in the medicine holistic quality control of internet plus era was discussed in this manuscript.

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