Technical requirements of the research on formula and preparation process of the generic drug product
Abstract：Generic drug is a main component of all drug products in China, and ensures the safe use by the public together with innovative drug. The generic injection is the most important type in all generic drugs be-cause its route of administration needs the highest requirement of quality control than any others. In order to furtherimprove our generic drug evaluation system and the quality of our evaluation and to enhance the efficiency of drug research and development, this article points out some requirements on preparation research of generic injection based on the principle of "The quality coherence between the innovative and the generic drug".
Keywords：generic druginjectionformula and process of preparations researchquality coherence
Publication Date：2010-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)