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Updated: Jun 18, 2025

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对于仿制产品的表征进行分析考虑:监管洞察

Akhilesh Kumar Kuril1, K Saravanan1, Praveen Kumar Subbappa2

  • 1Bhagwant University, Sikar Road, Ajmer, Rajasthan, India.

Analytical biochemistry
|August 1, 2024
PubMed
概括

酸治疗药物市场正在迅速扩大,通用酸变得越来越容易获得. 综合性表征对于证明仿制与参考产品的相同性至关重要,确保安全性和有效性.

关键词:
一种通用的酸.类药物治疗中的杂质.结构性表征结构性表征

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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