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Updated: Jun 27, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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对PMDA评估中的生物相似发展的比较临床研究数据包和样本大小的调查

Ryosuke Kuribayashi1,2, Aya Hariu3, Ayuki Nakano3

  • 1Office of Cellular and Tissue-Based Products, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. kuribayashi-ryosuke@pmda.go.jp.

Pharmaceutical medicine
|April 29, 2024
PubMed
概括

日本生物类似药的批准依赖于临床研究,如药理动力学 (PK) 和疗效试验. 样本大小各不相同,有效性研究通常需要更大的患者队列,特别是在瘤学和风湿病学中.

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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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