Ensuring Quality: The Role of Consistency Evaluation in Generic Drugs
There are many varieties and a huge number of generic drugs currently on the market, with varying quality and very different efficacy, and there is a certain gap between the quality of the reference listed drug (RLD). Therefore, generic drug consistency evaluation is imminent. Generic drug consistency evaluation is actually a re-evaluation process. The connotation of generic drug consistency evaluation is drug therapeutic equivalence, including pharmaceutical equivalence and bioequivalence. Among them, pharmaceutical equivalence refers to the similarity of the pharmaceutical properties of generic drugs and reference preparations, including raw materials and excipients, dosage forms, prescriptions, processes, in vitro experiments, and other studies. Pharmaceutical equivalence evaluation is the basic requirement for generic drug consistency evaluation.
Created: 02 Aug 2025 08:08:40 AM
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