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对抗补剂C5生物相似和原始单克隆抗体的比较强制降解研究

Merve Celik Yamaci1,2, Ceren Pamukcu2, Yigit Erdemgil2

  • 1Department of Medical Biotechnology, Institute of Health Sciences, Acibadem Mehmet Ali Aydinlar University, 34638 Istanbul, Türkiye.

Pharmaceuticals (Basel, Switzerland)
|April 26, 2025
PubMed
概括

在强制降解应力测试中,生物相似单克隆抗体的稳定性和降解概况与原始产品相似. 这证实了分析上的相似性,并确保了生物类似药的安全性和有效性.

关键词:
生物活动是生物活动.生物类似物 mAbAb毛细血管电泳 毛细血管电泳强制降解降解是一种强制性降解.电离聚焦是电离聚焦的方法.这是一种单克隆抗体.尺寸排除色谱法 尺寸排除色谱

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Bioequivalence: Overview01:16

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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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