A process evaluation method and system for generic drugs

Abstract

The embodiment of the present invention relates to a process evaluation method and system for generic drugs, so as to realize a more comprehensive process evaluation of drugs; further, it can better characterize the process information of key quality indicators. The method includes: obtaining national drug evaluation random test data of each drug to be evaluated, determining key quality indicators according to the national drug evaluation random test data; classifying and preprocessing the key quality indicators; determining each drug to be evaluated According to the value of the process information corresponding to the key quality index, the process evaluation result of each drug to be evaluated is determined according to the value of the process information; the process information includes individual process level distribution, inter-batch difference and abnormal product probability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a process evaluation method and system for generic drugs. Background technique [0002] In the pharmaceutical industry, huge costs and a lot of time are required to develop new drugs (original drugs). Therefore, companies (original research companies) that develop new drugs (original research drugs) obtain patent rights for the developed new drugs, and exclusively manufacture and sell the newly developed drugs of the company in order to recover the expenses required for development. In addition, if the term of patent protection for a new drug expires, other companies (generic companies) can also freely manufacture and sell drugs (generic drugs) that have substantially the same main ingredients as the original drug. Therefore, after the protection period of the patent expires, the original research drug and the generic drug appear on the market at the same time. [0003] In Feb...

AI Technical Summary

Problems solved by technology

[0006] Although the current drug quality standards are based on the QbD concept, the evaluation of drug quality still relies on the evaluation of a single index, which has certain limitations, mainly reflected in the fact that the evaluation of drug quality is one-sided, and drugs that meet the current quality standards cannot be evaluated. Fully guarantee clinical safety and effectiveness, etc.

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